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
4609–4632 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 24, 1997
FERR FLEX REAGENT CARTRIDGE
K963498 · JMG
Dade Chemistry Systems, Inc.
Chemistry · 143d
Cleared Jan 24, 1997
ELECSYS LH ASSAY
K964694 · CEP
Boehringer Mannheim Corp.
Chemistry · 63d
Cleared Jan 24, 1997
OPUS BONE ALP
K964764 · CIN
Behring Diagnostics, Inc.
Chemistry · 58d
Cleared Jan 24, 1997
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
K970082 · LCX
Abbott Laboratories
Chemistry · 15d
Cleared Jan 22, 1997
HCL - 200 BIOCHEMISTRY ANALYZER
K964409 · JJF
Hcl Laboratory Systems, Inc.
Chemistry · 79d
Cleared Jan 22, 1997
SEALITE SCIENCES, INC. AQUALITE LH
K964925 · CEP
Sealite Sciences, Inc.
Chemistry · 44d
Cleared Jan 21, 1997
GLUCOMETER DEX DIABETES CARE SYSTEM
K963500 · CGA
Bayer Corp.
Chemistry · 140d
Cleared Jan 21, 1997
AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST
K964574 · JHI
Athena Medical Corp.
Chemistry · 68d
Cleared Jan 21, 1997
ELECSYS PROLACTIN ASSAY
K964748 · CFT
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Jan 21, 1997
SAS ONE-STEP PREGNANCY
K964995 · JHI
Sa Scientific, Inc.
Chemistry · 36d
Cleared Jan 17, 1997
SIGMA DIAGNOSTICS GLUCOSE REAGENT
K963535 · CGA
Sigma Diagnostics, Inc.
Chemistry · 135d
Cleared Jan 17, 1997
AST/SGOT
K965126 · CIT
Derma Media Lab., Inc.
Chemistry · 25d
Cleared Jan 14, 1997
OLYMPUS LIPASE REAGENT
K963424 · CDT
Olympus America, Inc.
Chemistry · 137d
Cleared Jan 13, 1997
REP 3 QUTO-FLUR CHOLESTEROL-30
K962914 · JHO
Helena Laboratories
Chemistry · 171d
Cleared Jan 13, 1997
AIA-PACK B12 ASSAY
K964348 · CDD
Tosoh Medics, Inc.
Chemistry · 74d
Cleared Jan 13, 1997
ROCHE COBAS IBTEGRA REAGENT CASSETTES
K964457 · JQB
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared Jan 13, 1997
LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)
K965171 · JJY
Bio-Rad
Chemistry · 20d
Cleared Jan 10, 1997
GAMMA-GLUTAMYL TRANSPEPTIDASE
K964916 · JQB
Derma Media Lab., Inc.
Chemistry · 32d
Cleared Jan 09, 1997
LACTATE DEHYDROGENASE
K964912 · CFJ
Derma Media Lab., Inc.
Chemistry · 31d
Cleared Jan 09, 1997
VIDAS PROESTERONE (PRG) (30 409)
K965084 · JLS
bioMerieux, Inc.
Chemistry · 21d
Cleared Dec 26, 1996
UREA NITROGEN (BUN) LIQUI-UV
K962418 · CDQ
Stanbio Laboratory
Chemistry · 185d
Cleared Dec 26, 1996
STC AUTO-LYTE URINARY GLUCOSE ASSAY
K962435 · CFR
OraSure Technologies, Inc.
Chemistry · 185d
Cleared Dec 26, 1996
MODEL 5500 CEAS
K963938 · CHQ
Esa, Inc.
Chemistry · 86d
Cleared Dec 24, 1996
BRIO AUTOMATIC SAMPLINC UNIT
K961209 · JJF
Seac S.R.L.
Chemistry · 271d