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
8953–8976 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 05, 1986
MODEL K110SX CENTRIFUGE
K861146 · JQC
Jouan S.A.
Chemistry · 40d
Cleared May 05, 1986
THE JR. PARTNER SPECTROPHOTOMETER
K861223 · JJQ
Pharmacia, Inc.
Chemistry · 34d
Cleared May 02, 1986
POSID SAMPLER
K860508 · JQW
Organon Teknika Corp.
Chemistry · 80d
Cleared May 02, 1986
DIRECTACLONE CG SLIDE PREGNANCY TEST
K860945 · JHJ
Pacific Biotech, Inc.
Chemistry · 51d
Cleared May 01, 1986
VMA BY HPLC TEST (VANILMANDELIC ACID)
K861010 · CDF
Bio-Rad
Chemistry · 44d
Cleared Apr 30, 1986
ISOTRAK AMYLASE ISOENZYME CONTROL SET
K861329 · JJT
Behring Diagnostics, Inc.
Chemistry · 21d
Cleared Apr 29, 1986
TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
K860984 · CEP
Hybritech, Inc.
Chemistry · 43d
Cleared Apr 28, 1986
TSHK-NN RIA KIT
K860824 · JLW
Cis-Us, Inc.
Chemistry · 55d
Cleared Apr 28, 1986
IMMPULSE FREE ESTRIOL ASSAY REAGENTS
K860900 · CGI
Sclavo, Inc.
Chemistry · 49d
Cleared Apr 28, 1986
ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)
K861231 · CKA
Hi Chem, Inc.
Chemistry · 27d
Cleared Apr 28, 1986
AST REAGENT CARTRIDGE
K861283 · CIT
Hi Chem, Inc.
Chemistry · 21d
Cleared Apr 28, 1986
AP REAGENT CARTRIDGE
K861284 · CJE
Hi Chem, Inc.
Chemistry · 21d
Cleared Apr 28, 1986
HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE
K861419 · CFJ
Hi Chem, Inc.
Chemistry · 13d
Cleared Apr 28, 1986
QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID
K861448 · JJY
Quantimetrix Medical Industries
Chemistry · 47d
Cleared Apr 24, 1986
COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT
K860335 · JLX
Diagnostic Products Corp.
Chemistry · 85d
Cleared Apr 24, 1986
SERUM CHOLINESTERASE REAGENT SET
K860350 · DLI
Sterling Diagnostics, Inc.
Chemistry · 84d
Cleared Apr 24, 1986
LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.
K860713 · CFJ
Catachem, Inc.
Chemistry · 57d
Cleared Apr 24, 1986
ALP (ALKALINE PHOSPHATASE) REAGENT
K860715 · CJE
Trace Scientific , Ltd.
Chemistry · 57d
Cleared Apr 24, 1986
ENZYMATIC BUN REAGENT
K860716 · CDQ
Trace Scientific , Ltd.
Chemistry · 57d
Cleared Apr 24, 1986
CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE
K860733 · CGS
Trace Scientific , Ltd.
Chemistry · 57d
Cleared Apr 24, 1986
BETA QUIK STICK
K860965 · JHI
Pacific Biotech, Inc.
Chemistry · 42d
Cleared Apr 24, 1986
EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95
K861055 · JJE
Em Diagnostic Systems, Inc.
Chemistry · 36d
Cleared Apr 24, 1986
EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK
K861061 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Apr 24, 1986
CLEARBLUE PREGNANCY TESTING KIT
K861168 · LCX
Unipath , Ltd.
Chemistry · 27d