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
4633–4656 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 24, 1996
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
K962601 · CKG
Nichols Institute Diagnostics
Chemistry · 175d
Cleared Dec 24, 1996
WAKO DIRECT HDL-C
K963847 · JIS
Wako Chemicals USA, Inc.
Chemistry · 90d
Cleared Dec 24, 1996
QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964116 · LBZ
Bayer Corp.
Chemistry · 70d
Cleared Dec 23, 1996
REP 3 FLUR SPE-60 KIT
K964453 · CEF
Helena Laboratories
Chemistry · 47d
Cleared Dec 23, 1996
REP FLUR CHOLESTEROL-60 KIT
K964471 · JHO
Helena Laboratories
Chemistry · 46d
Cleared Dec 18, 1996
SYNERMED DIRECT BILIRUBIN REAGENT KIT
K963939 · CIG
Synermed, Inc.
Chemistry · 78d
Cleared Dec 18, 1996
VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964442 · LEG
Bayer Corp.
Chemistry · 42d
Cleared Dec 18, 1996
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4...
K964721 · KLI
Johnson & Johnson Clinical...
Chemistry · 23d
Cleared Dec 16, 1996
ELECSYS FT3
K963127 · CDP
Boehringer Mannheim Corp.
Chemistry · 126d
Cleared Dec 16, 1996
SIGMA DIAGNOSTICS WASH CONCENTRATE
K963539 · JJE
Sigma Diagnostics, Inc.
Chemistry · 103d
Cleared Dec 16, 1996
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS:...
K963934 · MMI
Bio-Rad Laboratories, Inc.
Chemistry · 76d
Cleared Dec 16, 1996
VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH...
K964558 · JLW
Johnson & Johnson Clinical...
Chemistry · 33d
Cleared Dec 16, 1996
ELECSYS FSH ASSAY
K964693 · CGJ
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared Dec 16, 1996
ELECSYS CALCHECK FSH
K964829 · JIX
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Dec 16, 1996
ELECSYS CALCHECK LH
K964830 · JJX
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Dec 13, 1996
CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1:...
K964640 · JJY
Canyon Diagnostics, Inc.
Chemistry · 24d
Cleared Dec 10, 1996
PORPHOBILINOGEN (PBG)
K961984 · JNF
Trace America, Inc.
Chemistry · 203d
Cleared Dec 10, 1996
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT
K962598 · CEW
Nichols Institute Diagnostics
Chemistry · 161d
Cleared Dec 06, 1996
CLINICAL BLOOD GAS MIXTURES
K964475 · JIS
Oxarc, Inc.
Chemistry · 29d
Cleared Dec 05, 1996
BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY...
K963770 · JJY
Biocircuits Corp.
Chemistry · 77d
Cleared Dec 04, 1996
EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST
K963231 · JHI
Excel Scientific, Inc.
Chemistry · 107d
Cleared Dec 03, 1996
FERRITIN CALIBRATOR
K963493 · JIT
Dade Chemistry Systems, Inc.
Chemistry · 91d
Cleared Dec 02, 1996
MIDSTREAM ONESTEP PREGNANCY HOME TEST
K963341 · LCX
Syntron Bioresearch, Inc.
Chemistry · 98d
Cleared Nov 29, 1996
ENZYMUN-TEST FT3
K962760 · CDP
Boehringer Mannheim Corp.
Chemistry · 136d