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
6433–6456 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 30, 1991
MICROTAK PLUS
K913840 · JJQ
Syva Co.
Chemistry · 35d
Cleared Sep 30, 1991
PROLACTIN IRMA IMMUNOMAG
K914107 · CFT
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 17d
Cleared Sep 27, 1991
KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST
K912499 · CHH
King Diagnostics, Inc.
Chemistry · 114d
Cleared Sep 27, 1991
STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO
K912852 · JLW
Baxter Healthcare Corp
Chemistry · 91d
Cleared Sep 27, 1991
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
K913130 · KHO
Baxter Healthcare Corp
Chemistry · 73d
Cleared Sep 27, 1991
CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)
K913133 · JJY
Bionostics, Inc.
Chemistry · 73d
Cleared Sep 27, 1991
ENZYMUN-TEST ESTRADIOL
K913162 · CHP
Boehringer Mannheim Corp.
Chemistry · 72d
Cleared Sep 27, 1991
AIA-PACK CK-MB
K913298 · JHX
Tosoh Corp.
Chemistry · 64d
Cleared Sep 27, 1991
ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34
K913706 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 39d
Cleared Sep 27, 1991
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
K913920 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 27, 1991
CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST
K914033 · JGY
Cholestech Corp.
Chemistry · 17d
Cleared Sep 25, 1991
TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES
K912616 · KLI
Technicon Instruments Corp.
Chemistry · 104d
Cleared Sep 25, 1991
J&S IRON REAGENTS
K912716 · JMO
J.S. Medical Assoc.
Chemistry · 99d
Cleared Sep 25, 1991
J&S UIBC REAGENTS
K912717 · JMO
J.S. Medical Assoc.
Chemistry · 99d
Cleared Sep 25, 1991
KODAK EKTACHEM DT SLIDES (LIPASE)
K913196 · CHT
Eastman Kodak Company
Chemistry · 69d
Cleared Sep 25, 1991
LIPID LINEARITY CONTROLS
K913224 · JJY
Creative Laboratory Products, Inc.
Chemistry · 68d
Cleared Sep 25, 1991
QUANTIMETRIX AMMONIA CONTROLS
K913346 · JJX
Quantimetrix Corp.
Chemistry · 61d
Cleared Sep 25, 1991
RAICHEM(TM) CREATINE KINASE-MB REAGENT
K913398 · CGS
Reagents Applications, Inc.
Chemistry · 57d
Cleared Sep 25, 1991
SELF-CONTAINED SURGICAL SLUSH FREEZER
K913777 · JRM
Taylor Corp.
Chemistry · 42d
Cleared Sep 25, 1991
HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL
K913792 · JJX
Hichem Diagnostics
Chemistry · 33d
Cleared Sep 19, 1991
CHEM-CHEX
K913687 · JJY
Streck Laboratories, Inc.
Chemistry · 31d
Cleared Sep 19, 1991
ABBOTT QUICKSTART ALANINE AMINOTRANSFER
K913846 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Sep 19, 1991
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
K913922 · JMO
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Sep 18, 1991
SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)
K911912 · KHQ
Serono-Baker Diagnostics, Inc.
Chemistry · 141d