FDA 510(k) Applications Submitted by BOREK JANIK
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K990250 |
01/26/1999 |
HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 |
MORAX |
| K960669 |
02/20/1996 |
HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS |
MORAX |
| K040925 |
04/08/2004 |
NORMAL AND HYPERGAMMA CONTROL SERUM |
SEBIA |
| K011113 |
04/11/2001 |
HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) |
SEBIA |
| K991362 |
04/14/1999 |
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) |
MORAX |
| K972015 |
05/30/1997 |
HYDRAGEL 7,15,30, CHOL-HDL KIT |
MORAX |
| K992148 |
06/24/1999 |
HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT |
MORAX |
| K022053 |
06/24/2002 |
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 |
SEBIA |
| K972591 |
07/11/1997 |
HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT |
MORAX |
| K012789 |
08/20/2001 |
MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 |
MORAX |
| K963844 |
09/25/1996 |
HYDRAGEL 15 HB A1C KIT |
MORAX |
| K033277 |
10/10/2003 |
HYDRAGEL CSF ISOFOCUSING KITS |
MORAX |
| K042939 |
10/25/2004 |
CAPILLARY'S IMMUNOTYPING (PN 2100) |
Sebia, Inc. |
| K974854 |
12/29/1997 |
HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 |
MORAX |
| K970477 |
02/07/1997 |
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT |
SEBIA |
| K981048 |
03/20/1998 |
HYDRAGEL 6 CSF KIT |
MORAX |
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