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
9289–9312 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 03, 1985
SERA-210 ELECTROLYTE ANALYZER
K853356 · CEM
Horiba Instruments, Inc.
Chemistry · 22d
Cleared Aug 30, 1985
SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV
K850368 · JIN
Sigma Chemical Co.
Chemistry · 211d
Cleared Aug 29, 1985
SYVA SOLID PHASE COLUMNS
K844948 · KEA
Syva Co.
Chemistry · 252d
Cleared Aug 29, 1985
HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE
K852867 · CKA
Hi Chem, Inc.
Chemistry · 52d
Cleared Aug 23, 1985
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT
K851703 · CGA
Miles Laboratories, Inc.
Chemistry · 121d
Cleared Aug 23, 1985
MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR
K853152 · JKA
Sherwood Medical Co.
Chemistry · 25d
Cleared Aug 23, 1985
DELTA TROL I & II
K853373 · JJT
Electro-Nucleonics Laboratories, Inc.
Chemistry · 11d
Cleared Aug 23, 1985
QCA POTASSIUM TEST KIT
K853404 · CEJ
Bd Becton Dickinson Vacutainer...
Chemistry · 11d
Cleared Aug 21, 1985
DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA
K851377 · CDD
Diagnon Corp.
Chemistry · 135d
Cleared Aug 21, 1985
CHLORIDE REAGENT
K852169 · CHJ
Pointe Scientific, Inc.,
Chemistry · 93d
Cleared Aug 21, 1985
IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN
K852441 · CJE
Clinical Data, Inc.
Chemistry · 72d
Cleared Aug 21, 1985
UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM
K852481 · JJQ
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Aug 20, 1985
BETA QUIK STAT
K852327 · JHI
Pacific Biotech, Inc.
Chemistry · 82d
Cleared Aug 19, 1985
125I ESTRADIOL DIRECT RADIOIMMUNOASSAY
K853208 · CHP
Travenol Laboratories, S.A.
Chemistry · 19d
Cleared Aug 19, 1985
URIC ACID REAGENT
K853357 · KNK
Sigma Diagnostics, Inc.
Chemistry · 7d
Cleared Aug 15, 1985
YSI MODEL 2372 TOTAL BLOOD LACTATE KIT
K852261 · KHP
Yellow Springs Instrument Co., Inc.
Chemistry · 83d
Cleared Aug 12, 1985
VISION POTASSIUM
K850950 · CEM
Abbott Laboratories
Chemistry · 158d
Cleared Aug 12, 1985
T-3 RIASSAY
K852537 · CDP
Ria Diagnostics
Chemistry · 59d
Cleared Aug 12, 1985
VISIDEX II REAGENT STRIPS
K852747
Miles Laboratories, Inc.
Chemistry · 46d
Cleared Aug 12, 1985
TRIGLYCERIDES LCK 124
K853041 · CDF
German American Chamber of Commerce,...
Chemistry · 24d
Cleared Aug 12, 1985
TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE
K853244 · CEK
Simmler, Inc.
Chemistry · 11d
Cleared Aug 07, 1985
AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI
K852948 · CFJ
Amresco, Inc.
Chemistry · 27d
Cleared Aug 06, 1985
DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS
K851618 · CGA
Home Diagnostics, Inc.
Chemistry · 110d
Cleared Aug 06, 1985
HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193
K853003 · JJE
Hi Chem, Inc.
Chemistry · 21d