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
5329–5352 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 05, 1995
IRMA BLOOD ANALYSIS SYSTEM
K945240 · CHL
Diametrics Medical, Inc.
Chemistry · 70d
Cleared Jan 05, 1995
CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO...
K945655 · CGX
Miles, Inc.
Chemistry · 49d
Cleared Dec 29, 1994
GLUCOSE QVET
K942963 · CFR
Prisma Systems
Chemistry · 189d
Cleared Dec 29, 1994
LACTATE DEHYDROGENASE QVET
K942964 · CFJ
Prisma Systems
Chemistry · 189d
Cleared Dec 29, 1994
ALKALINE PHOSPHATASE (ALKP) QVET
K942997 · CJE
Prisma Systems
Chemistry · 189d
Cleared Dec 29, 1994
MAGNESIUM QVET
K943001 · JGJ
Prisma Systems
Chemistry · 189d
Cleared Dec 29, 1994
BUN QVET
K943042 · CDN
Prisma Systems
Chemistry · 185d
Cleared Dec 29, 1994
STAT PROFILE ULTRA 11 ANALYZER
K943643 · CHL
Nova Biomedical Corp.
Chemistry · 155d
Cleared Dec 29, 1994
DYE CHECK STRIPS 545-630
K943729 · JJY
Awareness Technology, Inc.
Chemistry · 149d
Cleared Dec 28, 1994
NEOSCREEN ELISA HYDROXYPROGESTERONE
K940233 · JLX
Pantex
Chemistry · 344d
Cleared Dec 28, 1994
AQUALITE FSH
K943437 · CGJ
Sealite Sciences, Inc.
Chemistry · 163d
Cleared Dec 28, 1994
ACE(TM) CEDIA(R) PHENYTOIN ASSAY
K944085 · DIP
Schiapparelli Biosystems, Inc.
Chemistry · 128d
Cleared Dec 27, 1994
OLYMPUS MAGNESIUM REAGENT
K944407 · JGJ
Olympus America, Inc.
Chemistry · 110d
Cleared Dec 22, 1994
PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES
K945777 · JKA
Smiths Industries Medical Systems, Inc.
Chemistry · 27d
Cleared Dec 19, 1994
COAT-A-COUNT FREE ESTRIOL
K932989 · CGI
Diagnostic Products Corp.
Chemistry · 549d
Cleared Dec 19, 1994
IMMULITE RAPID TSH
K933212 · JLW
Diagnostic Products Corp.
Chemistry · 570d
Cleared Dec 19, 1994
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
K935399 · JLW
Bio-Rad
Chemistry · 405d
Cleared Dec 19, 1994
IMMULITE THIRD GENERATION (MODIFICATION)
K940006 · JLW
Diagnostic Products Corp.
Chemistry · 347d
Cleared Dec 19, 1994
IMMULITE PROGESTERONE
K944211 · JLS
Diagnostic Products Corp.
Chemistry · 112d
Cleared Dec 19, 1994
CORVAC PLASTIC BLOOD COLLECTION TUBE
K944814 · GIM
Sherwood Medical Co.
Chemistry · 81d
Cleared Dec 13, 1994
MODEL 3471 CLINICAL REFRACTOMETER
K941902 · JRE
Vee Gee Scientific, Inc.
Chemistry · 238d
Cleared Dec 13, 1994
MODEL A300CL CLINICAL REFRACTOMETER
K941904 · JRE
Vee Gee Scientific, Inc.
Chemistry · 238d
Cleared Dec 13, 1994
MODEL 3461 CLINICAL REFRACTOMETER
K941905 · JRE
Vee Gee Scientific, Inc.
Chemistry · 238d
Cleared Dec 13, 1994
ALBUMIN QVET
K943000 · CIX
Prisma Systems
Chemistry · 173d