FDA 510(k) Applications Submitted by DIAGNOSTIC SYSTEMS LABORATORIES, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020128 |
01/15/2002 |
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K020945 |
03/25/2002 |
AXSYM INTACT PTH, MODEL 2G06 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K990138 |
01/19/1999 |
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K001086 |
04/04/2000 |
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K981607 |
05/05/1998 |
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K981871 |
05/28/1998 |
C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K973243 |
08/29/1997 |
ACTIVE PSA ELISA (DSL-10-9700) |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K973244 |
08/29/1997 |
ACTIVE PSA IRMA (DSL-9700) |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K960060 |
01/04/1996 |
DSL ACTIVE PROLACTIN IRMA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K960171 |
01/16/1996 |
ACTIVE CROSSLAPS ELISA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K960357 |
01/25/1996 |
DSL ACTIVE I-HCG IRMA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K960550 |
02/08/1996 |
ACTIVE T3 RIA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K960551 |
02/08/1996 |
DSL ACTIVE HUMAN GROWTH HORMONE ELISA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K960561 |
02/09/1996 |
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K970915 |
03/12/1997 |
DSL ESTRONE-SULFATE RIA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K961109 |
03/20/1996 |
ACTIVE LH IRMA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K961172 |
03/25/1996 |
DSL ACTIVE NON-EXTRACTION IGF-I IRMA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K971269 |
04/04/1997 |
DSL ACTIVE T4 EIA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K971270 |
04/04/1997 |
DSL ACTIVE T3 EIA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K971353 |
04/11/1997 |
DSL ACTIVE NON-EXTRACTION IGF-I ELISA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K971823 |
05/16/1997 |
ACTIVE TESTOSTERONE EIA (DSL-10-4000) |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K961911 |
05/17/1996 |
DSL ACTIVE I-HCG ELISA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K962118 |
05/31/1996 |
DSL ACTIVE FSH IRMA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K962758 |
07/16/1996 |
DSL 9100 IGF-II IRMA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K962875 |
07/24/1996 |
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K962895 |
07/25/1996 |
DSL DHEA-S-7 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K963002 |
08/02/1996 |
ACTIVE ANDROSTENEDIONE EIA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K973514 |
09/17/1997 |
ACTIVE INTACT PTH |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K955114 |
11/09/1995 |
DSL AACTIVE DHEA EIA KIT |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K955356 |
11/21/1995 |
ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K970701 |
02/26/1997 |
DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K002128 |
07/14/2000 |
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K061758 |
06/22/2006 |
ACTIVE RENIN IRMA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
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