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
5353–5376 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 13, 1994
AST QVET
K944102 · CIT
Prisma Systems
Chemistry · 112d
Cleared Dec 12, 1994
CIBA CORNING ACS FOLATE ASSAY
K943297 · CGN
Ciba Corning Diagnostics Corp.
Chemistry · 157d
Cleared Dec 09, 1994
MICROREADER 4
K935983 · JJQ
Hyperion, Inc.
Chemistry · 360d
Cleared Dec 09, 1994
PHOSPHATE QVET
K942960 · CEO
Prisma Systems
Chemistry · 169d
Cleared Dec 09, 1994
AMYLASE QVET
K942961 · JFJ
Prisma Systems
Chemistry · 169d
Cleared Dec 09, 1994
CALCIUM QVET
K943003 · CJJ
Prisma Systems
Chemistry · 169d
Cleared Dec 09, 1994
TOTAL PROTEIN QVET
K943004 · CEK
Prisma Systems
Chemistry · 169d
Cleared Dec 09, 1994
POTASSIUM QVET
K943026 · CEJ
Prisma Systems
Chemistry · 165d
Cleared Dec 09, 1994
OLYMPUS AMYLASE REAGENT
K944229 · JFJ
Olympus America, Inc.
Chemistry · 100d
Cleared Dec 09, 1994
THYROXINE ENZYME IMMUNOASSAY
K944703 · KLI
Diagnostic Reagents, Inc.
Chemistry · 77d
Cleared Dec 09, 1994
IMX T3 ASSAY
K944808 · CDP
Organon Teknika Corp.
Chemistry · 71d
Cleared Dec 09, 1994
DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL
K945315 · JJY
Casco Standards
Chemistry · 38d
Cleared Dec 09, 1994
CLARIT(TM)
K945353 · JKA
Advanced Biomedical Methods, Inc.
Chemistry · 50d
Cleared Dec 07, 1994
GGT QVET
K942962 · JQB
Prisma Systems
Chemistry · 167d
Cleared Dec 07, 1994
CHLORIDE QVET
K943006 · CHJ
Prisma Systems
Chemistry · 167d
Cleared Dec 07, 1994
HDL QVET
K943028 · LBS
Prisma Systems
Chemistry · 163d
Cleared Dec 07, 1994
VISUALINE II HCG
K943239 · JHI
Sun Biomedical Laboratories, Inc.
Chemistry · 154d
Cleared Dec 07, 1994
PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416
K945322 · CEO
Emd Chemicals, Inc.
Chemistry · 36d
Cleared Dec 06, 1994
DMA CALCIUM PLUS PROCEDURE
K944255 · CJY
Data Medical Associates, Inc.
Chemistry · 96d
Cleared Dec 05, 1994
BOEHRINGER MANNHEIM BICARBONATE ASSAY
K933461 · KHS
Boehringer Mannheim Corp.
Chemistry · 507d
Cleared Dec 02, 1994
BILIRUBIN(TOTAL) QVET
K942999 · CIG
Prisma Systems
Chemistry · 162d
Cleared Dec 02, 1994
URIC ACID QVET
K943002 · KNK
Prisma Systems
Chemistry · 162d
Cleared Dec 02, 1994
IRON QVET
K943029 · JIY
Prisma Systems
Chemistry · 158d
Cleared Dec 02, 1994
ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC
K944231 · DIO
Roche Diagnostic Systems, Inc.
Chemistry · 93d