Syva Co., Dade Behring, Inc. - FDA 510(k) Cleared Devices
Recent clearances: EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229, EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229, EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
19
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Syva Co., Dade Behring, Inc. Toxicology ✕
14 devices
Cleared
Jul 02, 2001
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
Toxicology
12d
Cleared
Jun 18, 2001
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
Toxicology
24d
Cleared
Jun 12, 2001
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
Toxicology
19d
Cleared
May 17, 2001
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
Toxicology
17d
Cleared
May 16, 2001
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
Toxicology
16d
Cleared
May 15, 2001
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
Toxicology
29d
Cleared
May 15, 2001
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
Toxicology
18d
Cleared
May 10, 2001
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
Toxicology
24d
Cleared
May 02, 2001
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
Toxicology
16d
Cleared
Apr 26, 2001
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
Toxicology
27d
Cleared
Apr 26, 2001
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
Toxicology
27d
Cleared
Apr 20, 2001
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
Toxicology
23d
Cleared
Apr 20, 2001
EMIT 2000 GENTAMICIN PLUS ASSAY
Toxicology
18d
Cleared
Apr 13, 2001
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
Toxicology
25d