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
4849–4872 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 12, 1996
FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS
K953680 · JIN
Polymer Technology Intl.
Chemistry · 310d
Cleared Jun 12, 1996
CLINITEK 50 URINE CHEMISTRY ANALYZER
K960546 · KQO
Bayer Corp.
Chemistry · 125d
Cleared Jun 12, 1996
AVL 9180 ELECTROLYTE ANALYZER
K961458 · JFP
Avl Scientific Corp.
Chemistry · 58d
Cleared Jun 12, 1996
ELECSYS HCG ASSAY
K961487 · DHA
Boehringer Mannheim Corp.
Chemistry · 55d
Cleared Jun 12, 1996
ELECSYS T-UPTAKE ASSAY
K961488 · KHQ
Boehringer Mannheim Corp.
Chemistry · 55d
Cleared Jun 12, 1996
QUANTASE PHENYLALANINE ASSAY
K961515 · JNB
Shield Diagnostics, Ltd.
Chemistry · 63d
Cleared Jun 11, 1996
ELECSYS FT4 ASSAY
K961489 · CEC
Boehringer Mannheim Corp.
Chemistry · 54d
Cleared Jun 11, 1996
ELECSYS TROPONIN T
K961500 · MMI
Boehringer Mannheim Corp.
Chemistry · 54d
Cleared Jun 11, 1996
ELECSYS CK-MB
K961501 · JHW
Boehringer Mannheim Corp.
Chemistry · 54d
Cleared Jun 11, 1996
LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)
K961828 · JJT
Bio-Rad
Chemistry · 29d
Cleared Jun 10, 1996
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN...
K936135 · LAT
Sudormed, Inc.
Chemistry · 895d
Cleared Jun 03, 1996
HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL...
K961351 · DHA
Bayer Corp.
Chemistry · 59d
Cleared Jun 03, 1996
LACTATE DEHYDROGENASE REAGENT SET
K961431 · CFJ
Pointe Scientific, Inc.,
Chemistry · 49d
Cleared May 31, 1996
TBD AT-HOME PREGNANCY TEST
K961712 · LCX
Armkel, LLC
Chemistry · 29d
Cleared May 30, 1996
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
K955905 · CEK
Solarcare Technologies Corp,Inc.
Chemistry · 153d
Cleared May 30, 1996
UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE
K961236 · CDP
United Biotech, Inc.
Chemistry · 62d
Cleared May 30, 1996
GASTRIN EIA MODEL 06B-555017
K961276 · CGC
Biosyn , Ltd.
Chemistry · 57d
Cleared May 24, 1996
EKTACHEM DT LDL CHOLESTEROL KIT
K955904 · MRR
Johnson & Johnson Clinical...
Chemistry · 147d
Cleared May 23, 1996
BUHLMANN VITAMIN B6 REA
K955561 · CDD
American Laboratory Products Co., Ltd.
Chemistry · 169d
Cleared May 23, 1996
AST INCORPORATING DST
K961114 · CIT
Trace Scientific , Ltd.
Chemistry · 64d
Cleared May 17, 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)
K955286 · CGA
Johnson & Johnson Clinical...
Chemistry · 183d
Cleared May 15, 1996
ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
K955356 · CGI
Diagnostic Systems Laboratories, Inc.
Chemistry · 176d
Cleared May 15, 1996
CHEM-CHEX STAT
K961195 · JJY
Streck Laboratories, Inc.
Chemistry · 49d
Cleared May 15, 1996
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
K961196 · CDN
Johnson & Johnson Clinical...
Chemistry · 49d