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
4561–4584 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 03, 1997
THYROID STIMULATING HORMONE METHOD
K970393 · JLW
Dade Chemistry Systems, Inc.
Chemistry · 28d
Cleared Mar 03, 1997
ABBOTT HCG SERUM CONTROLS
K970527 · JJX
Abbott Laboratories
Chemistry · 20d
Cleared Feb 25, 1997
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
K970126 · CHP
Bio-Rad Laboratories, Inc.
Chemistry · 42d
Cleared Feb 25, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
K970281 · CFT
Johnson & Johnson Clinical...
Chemistry · 32d
Cleared Feb 20, 1997
SUPREME II METER
K963544 · CGA
Chronimed, Inc.
Chemistry · 169d
Cleared Feb 20, 1997
PRECISION G BLOOD GLUCOSE TESTING SYSTEM
K963676 · CGA
Medisense, Inc.
Chemistry · 160d
Cleared Feb 20, 1997
ACCUPACK PREGNANCY TEST
K964633 · JHI
Genix Biotek, Inc.
Chemistry · 93d
Cleared Feb 20, 1997
IRON REAGENT
K964913 · JIY
Derma Media Lab., Inc.
Chemistry · 73d
Cleared Feb 20, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH...
K964982 · CEP
Johnson & Johnson Clinical...
Chemistry · 70d
Cleared Feb 20, 1997
THE ADVANCED OSMOMETER (3900)
K965036 · JJM
Advanced Instruments, Inc.
Chemistry · 65d
Cleared Feb 20, 1997
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
K965116 · JHI
Abbott Laboratories
Chemistry · 62d
Cleared Feb 20, 1997
SEALITE SCIENCES, INC. AQUALITE PROLACTIN
K970188 · CFT
Sealite Sciences, Inc.
Chemistry · 34d
Cleared Feb 20, 1997
HUMAN CHORIONIC GONADOTROPIN CALIBRATOR
K970396 · JIW
Dade Chemistry Systems, Inc.
Chemistry · 17d
Cleared Feb 18, 1997
OLYMPUS ACID PHOSPHATASE REAGENT
K963640 · CKB
Olympus America, Inc.
Chemistry · 159d
Cleared Feb 18, 1997
VITROS CHEMISTRY PRODUCTS UPRO SLIDES
K964960 · JGP
Johnson & Johnson Clinical...
Chemistry · 69d
Cleared Feb 18, 1997
ELECSYS ESTRADIOL ASSAY
K965109 · CHP
Boehringer Mannheim Corp.
Chemistry · 60d
Cleared Feb 18, 1997
ALT/SGPT
K965134 · CKA
Derma Media Lab., Inc.
Chemistry · 57d
Cleared Feb 18, 1997
SAS SERUM/URINE HCG
K965250 · JHI
Sascie
Chemistry · 64d
Cleared Feb 18, 1997
SAS PREGNANCY STRIP
K965253 · JHI
Sascie
Chemistry · 64d
Cleared Feb 18, 1997
ADVANCED QUALITY PREGNANCY TEST
K970008 · LCX
Bionike, Inc.
Chemistry · 47d
Cleared Feb 18, 1997
THYROID CALIBRATOR
K970389 · JIT
Dade Chemistry Systems, Inc.
Chemistry · 15d
Cleared Feb 14, 1997
SEALITE SCIENCES AQUALITE FSH
K970085 · CGJ
Sealite Sciences, Inc.
Chemistry · 35d
Cleared Feb 14, 1997
MMB METHOD
K970343 · JHY
Dade Chemistry Systems, Inc.
Chemistry · 16d
Cleared Feb 11, 1997
ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST
K964461 · JHI
Teco Diagnostics
Chemistry · 96d