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
8737–8760 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 17, 1986
CHOLINESTERASE (BTC) REAGENT
K863203 · DIH
Sigma Diagnostics, Inc.
Chemistry · 29d
Cleared Sep 17, 1986
ALBUMIN (BCP)
K863226 · CJW
Sigma Diagnostics, Inc.
Chemistry · 27d
Cleared Sep 17, 1986
TOTAL BILIRUBIN PROCEDURE
K863262 · CIG
Data Medical Associates, Inc.
Chemistry · 23d
Cleared Sep 16, 1986
RIGHT-DAY OVULATION HOME TEST
K861354 · CEP
Leeco Diagnostics, Inc.
Chemistry · 159d
Cleared Sep 16, 1986
QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL
K861420 · JJY
Quantimetrix Corp.
Chemistry · 154d
Cleared Sep 16, 1986
VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)
K861449 · GIM
Exel Intl.
Chemistry · 152d
Cleared Sep 16, 1986
FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT
K862813 · CGJ
Serono Diagnostics, Inc.
Chemistry · 54d
Cleared Sep 16, 1986
EMDS(TM) CALCIUM TESTPACKS, #67687/95
K863003 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 39d
Cleared Sep 16, 1986
EMDS(TM) ALBUMIN TESTPACKS, #67652/95
K863004 · CJW
Em Diagnostic Systems, Inc.
Chemistry · 39d
Cleared Sep 16, 1986
CHOLINESTERASE (PTC) REAGENT
K863202 · DIH
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Sep 16, 1986
ALT/GPT PROCEDURE
K863253 · CKA
Data Medical Associates, Inc.
Chemistry · 22d
Cleared Sep 16, 1986
AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241
K863426 · JMO
American Research Products Co.
Chemistry · 12d
Cleared Sep 15, 1986
AKERSCAN COLORIMETRIC ANALYZER
K862908 · JJQ
Akers Medical Technologies
Chemistry · 46d
Cleared Sep 15, 1986
THERAPEUTIC DRUG MONITORING CONTROL SET
K862963 · JJY
American Monitor Corp.
Chemistry · 40d
Cleared Sep 15, 1986
ULTRASCAN CLINICAL ANALYZER
K862999 · JJQ
Specialty Medical Industries, Inc.
Chemistry · 38d
Cleared Sep 15, 1986
ABBOTT TESTPACK (TM) HCG SERUM
K863032 · JHI
Abbott Laboratories
Chemistry · 35d
Cleared Sep 15, 1986
TESTPACK ACUTE HCG SERUM CONTROLS
K863126 · JJX
Abbott Laboratories
Chemistry · 31d
Cleared Sep 15, 1986
TESTPACK ACUTE HCG URINGE CONTROLS
K863127 · JJW
Abbott Laboratories
Chemistry · 31d
Cleared Sep 15, 1986
CARDS(TM) HCG-URINE
K863199 · JHI
Pacific Biotech, Inc.
Chemistry · 27d
Cleared Sep 11, 1986
ALBUMETER
K863050 · CIX
J. D. Assoc.
Chemistry · 30d
Cleared Sep 11, 1986
CHOLESTEROL-E (FREE)
K863064 · CHH
J. D. Assoc.
Chemistry · 30d
Cleared Sep 11, 1986
FAST MUCOPROTEINS
K863070 · JQN
J. D. Assoc.
Chemistry · 30d
Cleared Sep 11, 1986
INORGANIC PHOSPHORUS PROCEDURE
K863264 · CEO
Data Medical Associates, Inc.
Chemistry · 17d
Cleared Sep 11, 1986
IRON PROCEDURE
K863266 · JIY
Data Medical Associates, Inc.
Chemistry · 17d