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
9145–9168 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 14, 1986
GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET
K855186 · JPZ
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
ENZYMATIC CHOLESTROL REAGENT SET
K855187 · CHH
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET
K855189 · CIQ
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
TOTAL PROTEIN REAGENT SET
K855191 · CEK
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
ALKALINE PHOSPHATASE REAGENT SET
K855192 · CIO
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
CREATININE REAGENT SET
K855193 · CGX
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
GLUCOSE OXIDASE REAGENT SET
K855194 · CGA
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
DIRECT & TOTAL BILIRUBIN SET
K855195 · CIG
Technostics Intl.
Chemistry · 19d
Cleared Jan 13, 1986
MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO
K854059 · JHI
Bioclinical Systems, Inc.
Chemistry · 102d
Cleared Jan 13, 1986
TERUMO SENSIBEAD EIA HPRL KIT
K854768 · CFT
Terumo Medical Corp.
Chemistry · 47d
Cleared Jan 13, 1986
RANGE-CHEK
K854789 · JJY
American Monitor Corp.
Chemistry · 45d
Cleared Jan 13, 1986
LEE-BEAD BETA FSH (EIA)
K854837 · CGJ
Leeco Diagnostics, Inc.
Chemistry · 41d
Cleared Jan 13, 1986
VISION CREATININE
K854846 · CGX
Abbott Laboratories
Chemistry · 40d
Cleared Jan 13, 1986
V-TREND OC CPK
K854973 · JJT
V-Tech, Inc.
Chemistry · 33d
Cleared Jan 13, 1986
CANWEST-PREGBLUE
K854989 · JHI
Canwest Medictex, Inc.
Chemistry · 32d
Cleared Jan 08, 1986
ABBOTT PHARAMACOKINETICS SYSTEMS
K851573 · NDC
Abbott Laboratories
Chemistry · 266d
Cleared Jan 08, 1986
ANALYST PHYSICIAN'S OFFICE PROFILER
K854523 · JJG
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 57d
Cleared Jan 07, 1986
ISOTRAK AMYLASE TEST AMYLASE ISOENZYME
K853951 · CIJ
Behring Diagnostics, Inc.
Chemistry · 104d
Cleared Jan 07, 1986
MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT
K854379 · JLW
Bioclinical Systems, Inc.
Chemistry · 69d
Cleared Jan 07, 1986
NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909
K854716 · CIC
Nobel Scientific Industries, Inc.
Chemistry · 46d
Cleared Jan 07, 1986
LEE-BEAD BETA LH (EIA)
K854838 · CEP
Leeco Diagnostics, Inc.
Chemistry · 35d
Cleared Jan 07, 1986
CRITIC - SF, ASSAYED
K854967 · JJY
Dimension Diagnostics
Chemistry · 27d
Cleared Dec 30, 1985
OSM3 HEMOXIMETER
K853990 · JKS
Radiometer America, Inc.
Chemistry · 94d
Cleared Dec 30, 1985
RAMP URINE HCG ASSAY
K854611 · JHI
Monoclonal Antibodies, Inc.
Chemistry · 42d