FDA 510(k) Applications Submitted by EDWARD M LEVINE PH.D.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120615 |
02/29/2012 |
ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE |
ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN |
| K041685 |
06/22/2004 |
ACON MULTI-CLIN DRUG SCREEN TEST DEVICE |
ACON LABORATORIES, INC. |
| K041946 |
07/19/2004 |
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE |
ACON LABORATORIES, INC. |
| K042272 |
08/23/2004 |
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) |
ACON LABORATORIES, INC. |
| K973186 |
08/25/1997 |
IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE |
DIAGNOSTIC PRODUCTS CORP. |
| K960067 |
01/05/1996 |
IMMILITE TOTAL IGE |
DIAGNOSTIC PRODUCTS CORP. |
| K980206 |
01/20/1998 |
IMMULITE ANTI-TG AB |
DIAGNOSTIC PRODUCTS CORP. |
| K962975 |
07/31/1996 |
PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) |
DIAGNOSTIC PRODUCTS CORP. |
| K963240 |
08/19/1996 |
IMMULITE ACTH CONTROL MODULE (LACCM) |
DIAGNOSTIC PRODUCTS CORP. |
| K963695 |
09/16/1996 |
IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ |
DIAGNOSTIC PRODUCTS CORP. |
| K963916 |
09/30/1996 |
IMMULITE CANNABINOIDS |
DIAGNOSTIC PRODUCTS CORP. |
| K963918 |
09/30/1996 |
IMMULITE COCAINE METABOLITE |
DIAGNOSTIC PRODUCTS CORP. |
| K034055 |
12/30/2003 |
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I |
DIAGNOSTIC PRODUCTS CORP. |
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