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
3529–3552 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 27, 2000
N/T PROTEIN CONTROL SL
K002852 · JJY
Dade Behring, Inc.
Chemistry · 75d
Cleared Nov 22, 2000
BIO-RAD %CDT TIA
K001651 · JJX
Axis-Shield Biochemicals, Asa
Chemistry · 176d
Cleared Nov 20, 2000
ACCESS ULTRASENSITIVE HGH CALIBRATORS
K003098 · JIT
Beckman Coulter, Inc.
Chemistry · 48d
Cleared Nov 20, 2000
MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K002199 · CFR
Pointe Scientific, Inc.,
Chemistry · 123d
Not Cleared Nov 20, 2000
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
DEN000010 · NBC
Biosite Incorporated
Chemistry · 5d
Cleared Nov 16, 2000
CREATININE PLUS
K003261 · JFY
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Nov 13, 2000
SOF-TACT DIABETES MANAGEMENT SYSTEM
K001993 · LFR
Abbott Laboratories
Chemistry · 137d
Cleared Nov 08, 2000
CARESIDE CHOLINESTERASE
K002792 · DIH
Careside, Inc.
Chemistry · 62d
Cleared Nov 02, 2000
MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
K002456 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 84d
Cleared Nov 02, 2000
ACCUWELL TSH, MODEL KAW-TSH-960
K001455 · JLW
Neometrics, Inc.
Chemistry · 177d
Cleared Nov 02, 2000
QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3
K001249 · JJY
Consolidated Technologies of Wisconsin
Chemistry · 204d
Cleared Oct 25, 2000
RAICHEM PHOSPORUS REAGENT
K003012 · CEO
Hemagen Diagnostics, Inc.
Chemistry · 29d
Cleared Oct 25, 2000
OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
K002982 · JJE
Olympus America, Inc.
Chemistry · 30d
Cleared Oct 19, 2000
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
K002613 · CHL
Nova Biomedical Corp.
Chemistry · 58d
Cleared Oct 13, 2000
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
K002651 · DCK
Pointe Scientific, Inc.,
Chemistry · 49d
Cleared Oct 12, 2000
INVERNESS MEDICAL OVULATION PREDICTOR TEST
K002867 · CEP
Selfcare, Inc.
Chemistry · 29d
Cleared Oct 12, 2000
BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
K002855 · JGS
Biocare Corp.
Chemistry · 29d
Cleared Oct 11, 2000
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974 · LDP
Dade Behring, Inc.
Chemistry · 55d
Cleared Oct 11, 2000
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL...
K002551 · LEG
Dade Behring, Inc.
Chemistry · 55d
Cleared Oct 05, 2000
N PROTEIN STANDARD SL
K002804 · JIX
Dade Behring, Inc.
Chemistry · 27d
Cleared Oct 05, 2000
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
K002799 · CFF
Beckman Coulter, Inc.
Chemistry · 27d
Cleared Oct 05, 2000
VACUETTE WITH PPACK
K002777 · JKA
Greiner Vacuette North America, Inc.
Chemistry · 29d
Cleared Oct 05, 2000
ELECSYS DHEA-S CALSET
K002760 · JIS
Roche Diagnostics Corp.
Chemistry · 30d
Cleared Oct 05, 2000
RANDOX MICROALBUMIN
K002674 · DDZ
Randox Laboratories, Ltd.
Chemistry · 38d