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
5641–5664 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 13, 1994
UROPAPER EIKEN 6B
K932368 · JIL
Tanabe U.S.A., Inc.
Chemistry · 269d
Cleared Jan 13, 1994
ALANINE AMINOTRANSFERASE (ALT) TEST
K935180 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 79d
Cleared Jan 11, 1994
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K930810 · CIN
Hybritech, Inc.
Chemistry · 328d
Cleared Jan 11, 1994
N-ASSAY TIA MICROALBUMIN
K934146 · JIR
Crestat Diagnostics, Inc.
Chemistry · 140d
Cleared Jan 11, 1994
RELIEF PLUS ONE REAGENT STRIP MODIFICATION
K934892 · CGA
Diagnostic Solutions, Inc.
Chemistry · 113d
Cleared Jan 11, 1994
MODEL 5500 CEAS
K934977 · CDF
Esa, Inc.
Chemistry · 84d
Cleared Jan 11, 1994
DIRECTDRAW SUPERSERUM-MINI
K935081 · JKA
International Technidyne Corp.
Chemistry · 78d
Cleared Jan 11, 1994
ONE STEP LH TEST
K935134 · CEP
Tcpi, Inc.
Chemistry · 75d
Cleared Jan 11, 1994
IMMULITE PROGESTERONE
K935138 · JLS
Diagnostic Products Corp.
Chemistry · 75d
Cleared Jan 11, 1994
CREATINE KINASE-MB (CK-MB) REAGENT SET
K935463 · CGS
Pointe Scientific, Inc.,
Chemistry · 60d
Cleared Jan 10, 1994
CHOLESTEROL ENZYMATIC ENDPOINT
K923504 · CHH
Randox Laboratories, Ltd.
Chemistry · 544d
Cleared Jan 10, 1994
IMMULITE ESTRADIOL
K932926 · CHP
Diagnostic Products Corp.
Chemistry · 209d
Cleared Jan 10, 1994
ACTIVE ANDROSTANEDIOL GLUCURONIDE
K934751 · CIZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 98d
Cleared Jan 03, 1994
ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT
K921868 · CFL
Endocrine Sciences Products
Chemistry · 623d
Cleared Jan 03, 1994
SIGMA ELECTROLYTE REFERENCE REAGENT
K933696 · JFL
Sigma Chemical Co.
Chemistry · 158d
Cleared Jan 03, 1994
860 MEASURMENT SYSTEM
K934907 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 80d
Cleared Jan 03, 1994
IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM
K935287 · JIY
Miles, Inc.
Chemistry · 61d
Cleared Dec 29, 1993
CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET
K934922 · JJX
Unipath , Ltd.
Chemistry · 77d
Cleared Dec 29, 1993
CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET
K934923 · JJX
Unipath , Ltd.
Chemistry · 77d
Cleared Dec 17, 1993
SIGMA BUN REAGENT
K933679 · LFP
Sigma Chemical Co.
Chemistry · 142d
Cleared Dec 17, 1993
SIGMA CO2 ALKALINE BUFFER REAGENT
K933691 · JFL
Sigma Chemical Co.
Chemistry · 141d
Cleared Dec 17, 1993
I-STAT IONIZED CALCIUM TEST
K934642 · JFP
I-Stat Corp.
Chemistry · 87d
Cleared Dec 17, 1993
EMDS PHOSPHOROUS (PHOS) TEST
K935178 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 52d
Cleared Dec 17, 1993
EMDS ALBUMIN (ALB) TEST
K935179 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 52d