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
9433–9456 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 20, 1985
TOTAL PROTEIN LIQUID STABLE REAGENT SET
K851877 · CEK
Medical Analysis Systems, Inc.
Chemistry · 21d
Cleared May 20, 1985
MULTI FUNCTION BLOOD GAS CONTROL
K851911 · JJS
Bionostics, Inc.
Chemistry · 19d
Cleared May 15, 1985
LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS
K850638 · MSJ
Behring Diagnostics, Inc.
Chemistry · 85d
Cleared May 14, 1985
GEN PROFILER SYSTEM
K851619 · JJG
Electro-Cucleonics, Inc.
Chemistry · 26d
Cleared May 13, 1985
ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18
K851154 · JQT
Astral Medical Systems
Chemistry · 52d
Cleared May 13, 1985
HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT
K851259 · CFL
Nichols Institute Diagnostics
Chemistry · 46d
Cleared May 13, 1985
CLINALYZER MODEL VX-1000
K851638 · JJE
Alpkem Corp.
Chemistry · 24d
Cleared May 10, 1985
COBAS CALIBRATOR SERUM
K850859 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared May 10, 1985
SPECTRA 1 FILTER PHOTOMETER
K850994 · JJQ
Awareness Technology, Inc.
Chemistry · 60d
Cleared May 10, 1985
SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P
K850995 · JJQ
Awareness Technology, Inc.
Chemistry · 60d
Cleared May 10, 1985
UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST
K851076 · JHI
United Biotech, Inc.
Chemistry · 53d
Cleared May 10, 1985
LD-1(IMMUNO) SEPARATION SET
K851521 · CEX
Seragen Diagnostics, Inc.
Chemistry · 25d
Cleared May 10, 1985
RFA-300 RAPID FLOW ANALYZER W/COMPUTER
K851542 · JJF
Alpkem Corp.
Chemistry · 24d
Cleared May 10, 1985
DEMAND MAGNESIUM
K851657 · JGJ
Cooper Biomedical, Inc.
Chemistry · 17d
Cleared May 10, 1985
CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/
K851670 · JIT
Medical Analysis Systems, Inc.
Chemistry · 17d
Cleared May 07, 1985
SMART ALEX II MULTI-FILTER PHOTOMETER
K850993 · JJQ
Awareness Technology, Inc.
Chemistry · 57d
Cleared May 07, 1985
AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM
K851361 · CGJ
Amersham Corp.
Chemistry · 33d
Cleared May 07, 1985
SANDARE IRON-BINDING CAPACITY PROCEDURE
K851395 · JMO
Sandare Chemical Co., Inc.
Chemistry · 28d
Cleared May 02, 1985
COBAS MIRA
K851172 · JJF
Roche Diagnostic Systems, Inc.
Chemistry · 41d
Cleared May 01, 1985
PREGNA-ZYME
K850992 · JHI
Armkel, LLC
Chemistry · 51d
Cleared Apr 30, 1985
TDX ANALYZER W/NEPHELOMETRY CAROUSEL
K851253 · JQX
Abbott Laboratories
Chemistry · 33d
Cleared Apr 30, 1985
SANDARE IRON PROCEDURE
K851394 · JIY
Sandare Chemical Co., Inc.
Chemistry · 21d
Cleared Apr 29, 1985
DSL PAP RIA -DSL#3100
K844679 · JFH
Diagnostic Systems Laboratories, Inc.
Chemistry · 150d
Cleared Apr 29, 1985
PTH-RIA
K844735 · CEW
Syncor Intl. Corp.
Chemistry · 146d