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
9049–9072 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 17, 1986
GLUCOSE HK-60 ASSAY KIT CAT. #201-39
K860625 · CFR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Mar 17, 1986
SANDARE BCG ALBUMIN PROCEDURE
K860684 · CIX
Sandare Chemical Co., Inc.
Chemistry · 20d
Cleared Mar 17, 1986
TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS
K860690 · CDT
Catachem, Inc.
Chemistry · 20d
Cleared Mar 14, 1986
CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS
K855091 · CDS
Sen Tech Medical Corp.
Chemistry · 84d
Cleared Mar 14, 1986
CAT-3 CATECHOLAMINE ASSAY KIT
K855214 · CHQ
Whale Scientific, Inc.
Chemistry · 74d
Cleared Mar 14, 1986
ENZYMATIC ALPHA-AMYLASE REAGENT KIT
K860245 · JFJ
Bio-Analytics Laboratories, Inc.
Chemistry · 49d
Cleared Mar 14, 1986
AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)
K860253 · CHO
Amersham Corp.
Chemistry · 49d
Cleared Mar 14, 1986
SERUM IRON & IRON BINDING REAGENT SET
K860478 · JIY
Sterling Diagnostics, Inc.
Chemistry · 35d
Cleared Mar 14, 1986
SERUM LIPASE REAGENT SET (TURBIDIMETRIC)
K860554 · CFG
Sterling Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 14, 1986
ANDROSTENEDIONE 125I KIT BY RIA
K860559 · CIZ
Immuchem Corp.
Chemistry · 28d
Cleared Mar 14, 1986
INORGANIC PHOSPHORUS REAGENT SET
K860628 · CEO
Sterling Diagnostics, Inc.
Chemistry · 23d
Cleared Mar 14, 1986
AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS
K860660 · CHS
Amresco, Inc.
Chemistry · 18d
Cleared Mar 14, 1986
AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT
K860661 · CIX
Amresco, Inc.
Chemistry · 18d
Cleared Mar 14, 1986
AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271
K860662 · CHJ
Amresco, Inc.
Chemistry · 18d
Cleared Mar 05, 1986
SKD ELECTROCHEMICAL SYSTEM (ECS)
K854723 · CEM
Smithkline Diagnostics, Inc.
Chemistry · 103d
Cleared Mar 05, 1986
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95
K855079 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Mar 05, 1986
CPK (UV) REAGENT KIT
K855188 · JHS
Technostics Intl.
Chemistry · 69d
Cleared Mar 05, 1986
ABL330 ACID BASE LABORATORY
K860057 · CHL
Radiometer America, Inc.
Chemistry · 58d
Cleared Mar 05, 1986
ENCORE PROLACTIN REAGENT
K860221 · CFT
Hybritech, Inc.
Chemistry · 42d
Cleared Mar 05, 1986
ACID PHOSPHATASE REAGENT SET
K860476 · CKE
Sterling Diagnostics, Inc.
Chemistry · 26d
Cleared Mar 05, 1986
MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY
K860490 · JHI
Medix Biotech, Inc.
Chemistry · 23d
Cleared Mar 05, 1986
TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT
K860542 · JHI
Hybritech, Inc.
Chemistry · 21d
Cleared Feb 28, 1986
IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS
K854094 · JLS
Immuchem Corp.
Chemistry · 144d
Cleared Feb 28, 1986
DELFIA TM HLH KIT
K855173 · CEP
Lkb Instruments, Inc.
Chemistry · 64d