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
8593–8616 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 31, 1986
BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT
K864939 · CDT
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Dec 22, 1986
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE
K863841 · LCX
Hybritech, Inc.
Chemistry · 82d
Cleared Dec 18, 1986
DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT
K864133 · JLW
Diagnostic Systems Laboratories, Inc.
Chemistry · 58d
Cleared Dec 17, 1986
ELECTROPHORESIS DATA CENTER (EDC)
K860645 · JQT
Helena Laboratories
Chemistry · 300d
Cleared Dec 16, 1986
NAPHTHYL PHOSPHATE, ACID PHOSPHATASE
K863832 · JFH
Pointe Scientific, Inc.,
Chemistry · 77d
Cleared Dec 16, 1986
UBI MAGIWEL(TM) PROLACTIN QUANTATIVE
K864075 · CFT
United Biotech, Inc.
Chemistry · 57d
Cleared Dec 16, 1986
UBI MAGIWEL(TM) TSH QUANTITATIVE
K864079 · JLW
United Biotech, Inc.
Chemistry · 57d
Cleared Dec 16, 1986
CIBA CORNING MAGIC(R) LITE TU IMMUNOASSAY
K864132 · KHQ
Ciba Corning Diagnostics Corp.
Chemistry · 56d
Cleared Dec 16, 1986
DSL-4800 ACTIVE TM TSH EIA SYSTEM
K864134 · JLW
Diagnostic Systems Laboratories, Inc.
Chemistry · 56d
Cleared Dec 16, 1986
IQ TRIGLYCERIDES
K864268 · CDT
Bd Becton Dickinson Vacutainer...
Chemistry · 48d
Cleared Dec 16, 1986
WAKO(TM) GOT II - HA
K864302 · CIT
Wako Chemicals USA, Inc.
Chemistry · 46d
Cleared Dec 16, 1986
TDX(R) II ANALYZER
K864319 · JJQ
Abbott Laboratories
Chemistry · 43d
Cleared Dec 16, 1986
WAKO GPT II - HA
K864335 · CKA
Wako Chemicals USA, Inc.
Chemistry · 42d
Cleared Dec 16, 1986
IQ URIC ACID TEST
K864341 · KNK
Bd Becton Dickinson Vacutainer...
Chemistry · 42d
Cleared Dec 16, 1986
VISION(TM) AMYLASE
K864435 · JFJ
Abbott Laboratories
Chemistry · 34d
Cleared Dec 16, 1986
IQ T4 IMMUNOASSAY
K864560 · CDX
Bd Becton Dickinson Vacutainer...
Chemistry · 27d
Cleared Dec 15, 1986
VIS-CUBE HCG (EIA)
K863933 · JHI
Leeco Diagnostics, Inc.
Chemistry · 68d
Cleared Dec 12, 1986
CREATINKINETIC
K863079 · CGX
J. D. Assoc.
Chemistry · 122d
Cleared Dec 10, 1986
ALT S.C.E. (GPT)
K863053 · CKA
J. D. Assoc.
Chemistry · 120d
Cleared Dec 10, 1986
LDH S.C.E.
K863068 · CFJ
J. D. Assoc.
Chemistry · 120d
Cleared Dec 10, 1986
PROTEINMETER
K863112 · JGP
J. D. Assoc.
Chemistry · 119d
Cleared Dec 10, 1986
MODIFIED SODIUM ELECTRODE
K863907 · JGS
Ionetics, Inc.
Chemistry · 64d
Cleared Dec 08, 1986
TRACKER SYSTEM
K860948 · CGA
Boehringer Mannheim Corp.
Chemistry · 271d
Cleared Dec 08, 1986
EXACTECH(TM)
K863468 · CGA
Travenol Laboratories, S.A.
Chemistry · 91d