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
5065–5088 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 27, 1995
ACCESS MYOGLOBIN REAGENTS
K951634 · DDR
Bio-Rad Laboratories, Inc.
Chemistry · 173d
Cleared Sep 26, 1995
SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM
K953994 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 33d
Cleared Sep 25, 1995
ACCESS ULTRASENSITIVE INSULIN ASSAY
K953084 · CFP
Bio-Rad Laboratories, Inc.
Chemistry · 84d
Cleared Sep 25, 1995
BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER
K953239 · JJE
Boehringer Mannheim Corp.
Chemistry · 76d
Cleared Sep 25, 1995
ABBOTT AXSYM PROLACTIN(MODIFICATION)
K953657 · CFT
Abbott Mfg., Inc.
Chemistry · 69d
Cleared Sep 21, 1995
ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
K950803 · JJT
Isolab, Inc.
Chemistry · 212d
Cleared Sep 21, 1995
CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE...
K952427 · CKA
Beckman Instruments, Inc.
Chemistry · 120d
Cleared Sep 20, 1995
IRON/TIBC REAGENT
K935712 · JIY
Horizon Diagnostics, Inc.
Chemistry · 659d
Cleared Sep 20, 1995
ROCHE CALIBRATOR SERUM
K942706 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 469d
Cleared Sep 20, 1995
VACUTAINER PLUS TUBES
K953463 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 58d
Cleared Sep 15, 1995
APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT
K950382 · JHN
Randox Laboratories, Ltd.
Chemistry · 227d
Cleared Sep 15, 1995
APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT
K950383 · JHN
Randox Laboratories, Ltd.
Chemistry · 227d
Cleared Sep 15, 1995
ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR
K952282 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 122d
Cleared Sep 08, 1995
ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
K951595 · CGX
Roche Diagnostic Systems, Inc.
Chemistry · 155d
Cleared Sep 08, 1995
IMMULITE HCG HIGH LEVEL CONTROL MODULE
K952251 · JJX
Diagnostic Products Corp.
Chemistry · 116d
Cleared Sep 06, 1995
GLUCOSE TEST ITEM NUMBER 97375/94
K951750 · LFR
Emd Chemicals, Inc.
Chemistry · 142d
Cleared Sep 06, 1995
URINARY METANEPHRINE KIT
K952919 · CHQ
Bioanalytical Systems, Inc.
Chemistry · 72d
Cleared Sep 06, 1995
HICHEM ISE DILUENT KIT 70008
K953860 · CGZ
Hichem Diagnostics
Chemistry · 20d
Cleared Sep 06, 1995
HICHEM ISE INTDERNAL REFERENCE KIT 70009
K953861 · CGZ
Hichem Diagnostics
Chemistry · 20d
Cleared Sep 06, 1995
HICHEM ISEKCI SOLUTION KIT 70010
K953862 · CGZ
Hichem Diagnostics
Chemistry · 20d
Cleared Sep 06, 1995
HICHEM ISE STANDARDS KIT 70011
K953863 · JIX
Hichem Diagnostics
Chemistry · 20d
Cleared Sep 05, 1995
FLUOROSCAN NEONATAL
K950415 · KHO
Isolab, Inc.
Chemistry · 217d
Cleared Sep 05, 1995
ELSA-HCT
K951708 · JKR
Cis-Us, Inc.
Chemistry · 145d
Cleared Sep 05, 1995
BIOSCAN
K952307 · JIL
Biosys Laboratories, Inc.
Chemistry · 111d