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
7009–7032 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 12, 1990
CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO)
K901137 · CEO
Technicon Instruments Corp.
Chemistry · 31d
Cleared Apr 11, 1990
DU PONT VISTA(R) IMMUNOASSAY SYSTEM
K900245 · JJQ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 84d
Cleared Apr 11, 1990
ENZYMUN TEST(R) TSH-S
K900277 · JLW
Boehringer Mannheim Corp.
Chemistry · 82d
Cleared Apr 11, 1990
AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583
K900394 · CDQ
American Research Products Co.
Chemistry · 72d
Cleared Apr 11, 1990
AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500
K900977 · CEO
American Research Products Co.
Chemistry · 39d
Cleared Apr 09, 1990
AUTOMATED EIA MICROPLATE READER MODELS EL312/312I
K901027 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 34d
Cleared Apr 09, 1990
AUTOMATED EIA MICROPLATE READER MODELS EL340/340I
K901059 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 34d
Cleared Apr 09, 1990
PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX
K901141 · JJC
Baxter Healthcare Corp
Chemistry · 27d
Cleared Apr 05, 1990
SALIVA ALCOHOL TEST
K894001 · DIC
Enzymatics C/O Burditt,Bowles,Radzius...
Chemistry · 304d
Cleared Apr 03, 1990
EXEC-WASH SOLID PHASE WASHING SYSTEM
K896631 · JQW
Source Scientific Systems, Inc.
Chemistry · 132d
Cleared Apr 03, 1990
SIGMA PROCEDURE NO. 735
K897147 · KHP
Sigma Diagnostics, Inc.
Chemistry · 98d
Cleared Apr 03, 1990
COULTER AMYLASE REAGENT
K900230 · JFJ
Coulter Corp.
Chemistry · 76d
Cleared Apr 03, 1990
COULTER CALCIUM REAGENT
K900231 · CJY
Coulter Corp.
Chemistry · 76d
Cleared Apr 03, 1990
NOVAPATH MICROPLATE READER
K900776 · JJQ
Bio-Rad
Chemistry · 42d
Cleared Apr 03, 1990
ENZYMUN TEST(R) LH
K900779 · CEP
Boehringer Mannheim Corp.
Chemistry · 42d
Cleared Apr 03, 1990
TECHNICON AXON SYSTEM REAGENT METHODS
K900905 · CKA
Technicon Instruments Corp.
Chemistry · 35d
Cleared Apr 03, 1990
ENZYMUN TEST(R) INSULIN
K901135 · CFP
Boehringer Mannheim Corp.
Chemistry · 22d
Cleared Apr 03, 1990
CEDIA (TM) CORTISOL ASSAY
K901296 · CGR
Microgenics Corp.
Chemistry · 14d
Cleared Mar 30, 1990
SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS
K897183 · JFL
Beckman Instruments, Inc.
Chemistry · 92d
Cleared Mar 30, 1990
ROCHE REAGENT FOR LDH
K900121 · CFJ
Roche Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Mar 30, 1990
DELFIA TBG KIT
K900240 · CEE
Pharmacia, Inc.
Chemistry · 72d
Cleared Mar 30, 1990
ENZYMUN TEST(R) PROLACTIN
K900695 · CFT
Boehringer Mannheim Corp.
Chemistry · 45d
Cleared Mar 30, 1990
ENZYMUN TEST(R) T4 (TOTAL THYROXINE)
K901086 · KLT
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Mar 29, 1990
GLUCOMETER GX BLOOD GLUCOSE METER
K897015 · CGA
Heraeus Kulzer, Inc.
Chemistry · 100d