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
6049–6072 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 26, 1992
CHOLESTEROL TEST
K923733 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 91d
Cleared Oct 26, 1992
STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
K924074 · CDD
Baxter Diagnostics, Inc.
Chemistry · 75d
Cleared Oct 22, 1992
ROCHE REAGENT FOR ALT
K924245 · CKA
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Oct 19, 1992
STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY
K922073 · DHA
Baxter Diagnostics, Inc.
Chemistry · 168d
Cleared Oct 19, 1992
PREMIER C. DIFFICILE TOXIN A CONTROLS
K924136 · LLH
Meridian Diagnostics, Inc.
Chemistry · 62d
Cleared Oct 19, 1992
OLYMPUS AMYLASE REAGENT
K924339 · CIW
Olympus Corp.
Chemistry · 52d
Cleared Oct 19, 1992
OLYMPUS CALCIUM REAGENT
K924435 · CIC
Olympus Corp.
Chemistry · 48d
Cleared Oct 19, 1992
OLYMPUS MAGNESIUM REAGENT
K924658 · JGJ
Olympus Corp.
Chemistry · 34d
Cleared Oct 19, 1992
OLYMPUS CREATININE REAGENT
K924692 · CGX
Olympus Corp.
Chemistry · 32d
Cleared Oct 15, 1992
CK-NAC ACTIVATED KIT
K923511 · CGS
Randox Laboratories, Ltd.
Chemistry · 92d
Cleared Oct 15, 1992
VISTA TRIIODOTHYRONINE ASSAY
K923571 · CDP
Syva Co.
Chemistry · 90d
Cleared Oct 15, 1992
CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2
K924599 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Oct 14, 1992
KODAK AMERLEX MAB FT3 ASSAY
K922771 · CDP
Eastman Kodak Company
Chemistry · 127d
Cleared Oct 14, 1992
TECHNICON DAX SYSTEM THYROXINE (T4) METHOD
K922945 · CDX
Heraeus Kulzer, Inc.
Chemistry · 118d
Cleared Oct 14, 1992
ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM
K923048 · CGA
Boehringer Mannheim Corp.
Chemistry · 112d
Cleared Oct 14, 1992
REDI-CHECK PHOTMETER Q.A.
K923598 · JFS
Awareness Technology, Inc.
Chemistry · 86d
Cleared Oct 14, 1992
TWO PART INORGANIC PHOSPHORUS TEST
K924470 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Oct 13, 1992
NOVA NA/K/CL/LI MODULE
K922943 · CEM
Nova Biomedical Corp.
Chemistry · 117d
Cleared Oct 13, 1992
KING DIAGNOSTICS UREA NITROGEN REAGENT
K922969 · CDN
King Diagnostics, Inc.
Chemistry · 116d
Cleared Oct 13, 1992
MICROLITE MICROTITER PLATE LUMINOMETER ML3000
K923456 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 91d
Cleared Oct 13, 1992
MULTIQUAL UNASSAYED PRODUCTS
K923632 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 84d
Cleared Oct 13, 1992
MULTIQUAL ASSAY PRODUCTS
K923633 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 84d
Cleared Oct 13, 1992
ACCUDATA GLUCOSE TEST STATION
K924475 · CGA
Boehringer Mannheim Corp.
Chemistry · 40d
Cleared Oct 13, 1992
CREATINE KINASE (CK) TEST ITEM #65411
K924704 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 26d