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
9361–9384 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 28, 1985
ECHOCLONAL HCG IRMA
K852201 · JHI
Bio-Rad
Chemistry · 38d
Cleared Jun 28, 1985
ANSWER
K852274 · LCX
Armkel, LLC
Chemistry · 30d
Cleared Jun 26, 1985
ALBUMIN
K850931 · CIX
Dilab, Inc.
Chemistry · 111d
Cleared Jun 25, 1985
PHOTOMETER VARIOUS ONE FOR MICROTITERPLATES
K844894 · JJQ
Slt Labinstruments, Inc.
Chemistry · 190d
Cleared Jun 25, 1985
BHCG-ROCHE EIA
K850727 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 123d
Cleared Jun 25, 1985
CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/
K850907 · JJT
Cala Diagnostics
Chemistry · 112d
Cleared Jun 25, 1985
CREATININE
K850932 · CGX
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
URIC ACID
K850933 · CDH
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
PHOSPHORUS
K850934 · CEO
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
TOTAL PROTEINS
K850936 · CEK
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
CHOLESTEROL
K850938 · CGO
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
CK/LD ISOENZYMES CONTROLS(HUMAN)
K851520 · JJT
Seragen Diagnostics, Inc.
Chemistry · 71d
Cleared Jun 25, 1985
ELECTROLYTE ANALYZER
K851808 · CEM
Ionetics, Inc.
Chemistry · 71d
Cleared Jun 25, 1985
TANDEM E PAP
K851950 · JFH
Hybritech, Inc.
Chemistry · 53d
Cleared Jun 25, 1985
INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU
K851990 · JIX
Alpkem Corp.
Chemistry · 49d
Cleared Jun 25, 1985
CA BUFFER CA DYE
K852002 · CIC
Alpkem Corp.
Chemistry · 49d
Cleared Jun 25, 1985
MG REAGENT
K852005 · JGJ
Alpkem Corp.
Chemistry · 49d
Cleared Jun 25, 1985
PREGNANCY CARD TEST
K852066 · JHJ
Em Diagnostic Systems, Inc.
Chemistry · 46d
Cleared Jun 25, 1985
ASSIST CLINICAL CHEMISTRY ANALYZER
K852262 · JJE
Cooper Biomedical, Inc.
Chemistry · 32d
Cleared Jun 19, 1985
WHITESIDE ACRYLIC CEMENT SPACER SLEEVE
K844637 · LTC
Dow Corning Corp. Healthcare...
Chemistry · 203d
Cleared Jun 14, 1985
CORNING CERTAIN -ISE
K851939 · JIX
Corning Medical & Scientific
Chemistry · 42d
Cleared Jun 13, 1985
MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA
K851329 · JLW
Corning Medical & Scientific
Chemistry · 70d
Cleared Jun 10, 1985
CALCIUM
K850929 · CIC
Dilab, Inc.
Chemistry · 95d
Cleared Jun 10, 1985
GLUCOSE
K850930 · CGE
Dilab, Inc.
Chemistry · 95d