FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
4129–4152 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 08, 1998
DADE TRU-LIQUID CARDIAC CONTROL
K981622 · JJX
Dade Behring, Inc.
Chemistry · 32d
Cleared Jun 08, 1998
CO2
K981840 · KHS
Abbott Laboratories
Chemistry · 13d
Cleared Jun 05, 1998
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
K980996 · KHS
Roche Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Jun 05, 1998
3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K981312 · JLW
Bayer Corp.
Chemistry · 56d
Cleared Jun 05, 1998
RAPIDHCG PREGNANCY TEST
K981770 · JHI
Rapid Diagnostics, Inc.
Chemistry · 17d
Cleared Jun 03, 1998
BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30
K981609 · CIG
Diagnostic Chemicals , Ltd.
Chemistry · 29d
Cleared Jun 03, 1998
QUIDEL HOME PREGNANCY TEST
K981722 · LCX
Quidel Corp.
Chemistry · 19d
Cleared Jun 01, 1998
DIASCREEN REAGENT STRIPS
K981555 · LJX
Chronimed, Inc.
Chemistry · 31d
Cleared May 29, 1998
CREATININE (CREA)
K981240 · CGX
Abbott Laboratories
Chemistry · 53d
Cleared May 28, 1998
ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005...
K981512 · JHI
Skd, Inc. A Beckman Coulter Co.
Chemistry · 30d
Cleared May 27, 1998
ALKPHASE-B ASSAY KIT
K981373 · CIN
Metra Biosystems, Inc.
Chemistry · 41d
Cleared May 27, 1998
ALBP
K981457 · CJW
Abbott Mfg., Inc.
Chemistry · 34d
Cleared May 27, 1998
ALBG
K981468 · CIX
Abbott Laboratories
Chemistry · 34d
Cleared May 27, 1998
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
K981607 · CIB
Diagnostic Systems Laboratories, Inc.
Chemistry · 22d
Cleared May 26, 1998
STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK
K981099 · JHX
Dade Behring, Inc.
Chemistry · 61d
Cleared May 22, 1998
ACCU-CHEK COMFORT CURVE TEST STRIPS
K980731 · LFR
Boehringer Mannheim Corp.
Chemistry · 86d
Cleared May 21, 1998
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA...
K974695 · CKB
Roche Diagnostic Systems, Inc.
Chemistry · 156d
Cleared May 20, 1998
ALKALINE PHOSPHATASE (ALKP)
K981245 · CJE
Abbott Laboratories
Chemistry · 44d
Cleared May 20, 1998
TIBC
K981279 · JMO
Abbott Laboratories
Chemistry · 42d
Cleared May 18, 1998
CA
K981232 · CJY
Abbott Mfg., Inc.
Chemistry · 45d
Cleared May 18, 1998
LD-1
K981338 · JGF
Abbott Laboratories
Chemistry · 35d
Cleared May 18, 1998
BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS
K981401 · JJY
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared May 13, 1998
THIRD GENERATION PSA CONTROL MODULE
K981455 · JJY
Diagnostic Products Corp.
Chemistry · 20d
Cleared May 12, 1998
CO2
K981231 · KHS
Abbott Mfg., Inc.
Chemistry · 39d