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
8089–8112 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 14, 1987
PARAMAX ISE CHLORIDE CALIBRATOR
K873743 · JIT
Baxter Healthcare Corp
Chemistry · 89d
Cleared Dec 14, 1987
MULTI-FUNCTION BLOOD GAS CONTROL
K874408 · JJS
Bionostics, Inc.
Chemistry · 47d
Cleared Dec 04, 1987
CRESOLPHTHALEIN COMPLEXONE, CALCIUM
K874131 · CIC
Pointe Scientific, Inc.,
Chemistry · 52d
Cleared Dec 01, 1987
ABBOTT PAP-EIA
K873903 · JFH
Abbott Laboratories
Chemistry · 68d
Cleared Nov 27, 1987
LAD MODEL 735 LUMINOMETER
K874262 · JJQ
Los Alamos Diagnostics
Chemistry · 38d
Cleared Nov 25, 1987
O.P.T.(TM) OVULATION PREDICTION TEST
K870584 · CEP
Warner-Lambert Co.
Chemistry · 287d
Cleared Nov 25, 1987
IQ/QCA TOTAL BILIRUBIN
K874261 · CIG
Bd Becton Dickinson Vacutainer...
Chemistry · 36d
Cleared Nov 25, 1987
MULTICHEM (R) TOTAL BILIRUBIN
K874311 · CIG
Simmler, Inc.
Chemistry · 36d
Cleared Nov 25, 1987
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
K874476 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Nov 24, 1987
NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY
K873737 · CDP
Cambridge Medical Technology
Chemistry · 70d
Cleared Nov 24, 1987
GLUCOSE-HK REAGENT
K873835 · CFR
Intersect Systems, Inc.
Chemistry · 64d
Cleared Nov 24, 1987
TITAN GEL REP LDH-30 HV
K874142 · CFE
Helena Laboratories
Chemistry · 42d
Cleared Nov 24, 1987
TITAN GEL REP LDH-6 HV
K874145 · CFE
Helena Laboratories
Chemistry · 42d
Cleared Nov 24, 1987
EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683
K874397 · LBS
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Nov 24, 1987
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY
K874578 · KLS
Syva Co.
Chemistry · 18d
Cleared Nov 23, 1987
PROTEIN STANDARD CALIBRATOR
K871755 · JIX
Wako Chemicals USA, Inc.
Chemistry · 202d
Cleared Nov 23, 1987
REFLOTRON BILIRUBIN
K872818 · CIG
Boehringer Mannheim Corp.
Chemistry · 130d
Cleared Nov 23, 1987
PARAMAX PHOSPHORUS REAGENT
K873454 · CEO
Baxter Healthcare Corp
Chemistry · 87d
Cleared Nov 23, 1987
PARAMAX URIC ACID REAGENT
K873456 · KNK
Baxter Healthcare Corp
Chemistry · 87d
Cleared Nov 23, 1987
PARAMAX AMYLASE REAGENT
K873520 · CJA
Baxter Healthcare Corp
Chemistry · 83d
Cleared Nov 23, 1987
PARAMAX CREATININE REAGENT
K873531 · CGX
Baxter Healthcare Corp
Chemistry · 83d
Cleared Nov 23, 1987
PARAMAX UREA NITROGEN REAGENT
K873532 · CDQ
Baxter Healthcare Corp
Chemistry · 83d
Cleared Nov 23, 1987
OVUGEN SURETEST
K873534 · CEP
Biogenex Laboratories
Chemistry · 83d
Cleared Nov 23, 1987
CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504
K873788 · JHI
Pacific Biotech, Inc.
Chemistry · 67d