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
7705–7728 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 25, 1988
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II
K882486 · JJY
Bio-Rad
Chemistry · 131d
Cleared Oct 25, 1988
CHEM 1 UIBC (IRON BINDING CAPACITY TEST)
K883104 · JMO
Technicon Instruments Corp.
Chemistry · 92d
Cleared Oct 25, 1988
CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST
K883321 · JJE
Heraeus Kulzer, Inc.
Chemistry · 81d
Cleared Oct 25, 1988
ROCHE REAGENT FOR CALCIUM
K883453 · CJY
Roche Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Oct 25, 1988
STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME
K883479 · CDP
Baxter Healthcare Corp
Chemistry · 70d
Cleared Oct 25, 1988
OXALATE REAGENT
K883525 · LPW
Sigma Chemical Co.
Chemistry · 69d
Cleared Oct 25, 1988
QLIA T UPTAKE ASSAY
K883971 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Oct 20, 1988
TDX AMPHETAMINE/METHAMPHETAMINE II
K883707 · DKZ
Abbott Laboratories
Chemistry · 51d
Cleared Oct 13, 1988
CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY
K882560 · CEW
Ciba Corning Diagnostics Corp.
Chemistry · 114d
Cleared Oct 13, 1988
TECHNICON RA(TM) SYSTEMS - MAGNESIUM
K883326 · JGJ
Technicon Instruments Corp.
Chemistry · 66d
Cleared Oct 13, 1988
ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)
K883387 · CKD
Tech-Co, Inc.
Chemistry · 64d
Cleared Oct 13, 1988
DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST
K883861 · JJY
Casco Standards
Chemistry · 30d
Cleared Oct 13, 1988
CIBA CORNING MAGIC LITE HCG IMMUNOASSAY
K883927 · JHI
Ciba Corning Diagnostics Corp.
Chemistry · 28d
Cleared Oct 13, 1988
VISION CREATINE KINASE
K883946 · CGS
Abbott Laboratories
Chemistry · 24d
Cleared Oct 12, 1988
MODIFIED BETA QUIK STAT EIA KIT
K882895 · DHA
Pacific Biotech, Inc.
Chemistry · 93d
Cleared Oct 12, 1988
TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS
K883792 · JIY
Catachem, Inc.
Chemistry · 35d
Cleared Oct 11, 1988
AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA
K882736 · JJY
Amersham Corp.
Chemistry · 102d
Cleared Oct 06, 1988
BLUE DOT(TM) TEST FOR PREGNANCY
K882588 · LCX
V-Tech, Inc.
Chemistry · 105d
Cleared Oct 06, 1988
AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190
K882728 · JJY
Amersham Corp.
Chemistry · 97d
Cleared Oct 06, 1988
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY
K883305 · CGJ
Binax, Inc.
Chemistry · 63d
Cleared Oct 06, 1988
BINAS LUTEINIZING HORMONE IRMA TEST KIT
K883306 · JIT
Binax, Inc.
Chemistry · 63d
Cleared Oct 06, 1988
CHLORIDE
K883386 · CHJ
Tech-Co, Inc.
Chemistry · 57d
Cleared Oct 06, 1988
MODIFIED HCG IRMA KIT
K883639 · JHI
Pacific Biotech, Inc.
Chemistry · 42d
Cleared Oct 06, 1988
CLEARVIEW HCG
K883777 · JHI
Unipath , Ltd.
Chemistry · 30d