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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
12865–12888 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 13, 1977
HOLESTEROL DELTA TEST ASSAY
K771582 · CHH
Bd Becton Dickinson Vacutainer...
Chemistry · 26d
Cleared Sep 13, 1977
T3 UPTAKE DIAG. KIT
K771585
Antibodies, Inc.
Chemistry · 26d
Cleared Sep 13, 1977
IN VITRO FOLATE RADIOASSAY KIT
K771597 · CGN
Clinical Assays, Inc.
Chemistry · 25d
Cleared Sep 13, 1977
MULTISTAT III, TOTAL BILIRUBIN TEST
K771621 · CIG
Instrumentation Laboratory CO
Chemistry · 19d
Cleared Sep 13, 1977
MULTISTAT III, AMYLASE TEST
K771622 · JFJ
Instrumentation Laboratory CO
Chemistry · 19d
Cleared Sep 12, 1977
AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI
K771004 · CDT
Miles Laboratories, Inc.
Chemistry · 102d
Cleared Sep 12, 1977
MULTISTAT III CALCIUM TEST
K771468 · CIA
Instrumentation Laboratory CO
Chemistry · 39d
Cleared Sep 12, 1977
MULTISTAT III MAGNESIUM TEST
K771469 · JGJ
Instrumentation Laboratory CO
Chemistry · 39d
Cleared Sep 12, 1977
MULTISTAT III ALKALINE PHOSPHATASE
K771470 · CJE
Instrumentation Laboratory CO
Chemistry · 39d
Cleared Sep 12, 1977
MULTISTAT III GLUCOSE TEST
K771471 · CGA
Instrumentation Laboratory CO
Chemistry · 39d
Cleared Sep 12, 1977
MULTISTAT III TOTAL PROTEIN TEST
K771476 · CEK
Instrumentation Laboratory CO
Chemistry · 39d
Cleared Sep 12, 1977
MULTISTAT III PHOSPHOROUS TEST
K771477 · CEO
Instrumentation Laboratory CO
Chemistry · 39d
Cleared Sep 12, 1977
PREGNANCY TEST KIT
K771514 · JHJ
Generic Laboratory, Ltd.
Chemistry · 35d
Cleared Sep 12, 1977
MIDDLEBROOK 7H11 AGAR (PLATE)
K771661 · JSJ
Granite Diagnostics, Inc.
Chemistry · 13d
Cleared Sep 02, 1977
HYPRONOSTICON TM
K770603 · JMM
Organon, Inc.
Chemistry · 156d
Cleared Sep 02, 1977
TRIGLYCERIDE REAGENT SET
K770993 · CDT
Macomb Chemical Co.
Chemistry · 93d
Cleared Sep 02, 1977
3-(N-MORPHOLINS)-PROPANE SULFONIC ACID
K771324 · JHX
Corning Medical & Scientific
Chemistry · 46d
Cleared Sep 02, 1977
THYRODOT-4, THYRODOT-SH
K771377 · JLW
Medcom Diagnostics, Inc.
Chemistry · 39d
Cleared Sep 02, 1977
IMMUNOSTAT T3 UPTAKE TEST
K771382
Meloy Laboratories, Inc.
Chemistry · 38d
Cleared Sep 02, 1977
AMYLASE ULTRAZYME PLUS
K771388 · JFJ
Harleco
Chemistry · 37d
Cleared Sep 02, 1977
CK-1 ULTRAZYME PLUS
K771389 · CGS
Harleco
Chemistry · 37d
Cleared Sep 02, 1977
SERONORM
K771436 · JJT
Nyegaard & Co. A/S
Chemistry · 32d
Cleared Sep 02, 1977
SERONORM LIPID
K771437 · JJY
Nyegaard & Co. A/S
Chemistry · 32d
Cleared Sep 02, 1977
AUTONORM
K771438 · JJT
Nyegaard & Co. A/S
Chemistry · 32d