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
4441–4464 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 20, 1997
TRIGLYCERIDES, TG, OR TRIG
K971324 · CDT
Carolina Liquid Chemistries Corp.
Chemistry · 71d
Cleared Jun 18, 1997
N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR,...
K971573 · LBR
Genzyme Corp.
Chemistry · 49d
Cleared Jun 18, 1997
OPUS PROGESTERONE
K971725 · JLS
Behring Diagnostics, Inc.
Chemistry · 40d
Cleared Jun 18, 1997
QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND...
K972080 · JJY
Consolidated Technologies, Inc.
Chemistry · 15d
Cleared Jun 17, 1997
VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
K971449 · GIM
Becton Dickinson Vacutainer Systems
Chemistry · 57d
Cleared Jun 17, 1997
CREA OR CREATININE
K971908 · CGX
Carolina Liquid Chemistries Corp.
Chemistry · 25d
Cleared Jun 17, 1997
BUN
K971967 · CDQ
Carolina Liquid Chemistries Corp.
Chemistry · 20d
Cleared Jun 16, 1997
TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER
K971111 · JKA
Tri-Tech, Inc.
Chemistry · 82d
Cleared Jun 16, 1997
LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR
K971162 · LBS
Genzyme Corp.
Chemistry · 77d
Cleared Jun 16, 1997
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
K971190 · LBS
Genzyme Corp.
Chemistry · 77d
Cleared Jun 16, 1997
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
K971276 · CFR
Bayer Corp.
Chemistry · 70d
Cleared Jun 16, 1997
SPECIALITY URINE 1,2
K971405 · JJY
Chiron Diagnostics Corp.
Chemistry · 61d
Cleared Jun 16, 1997
SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
K971467 · CFR
Carolina Liquid Chemistries Corp.
Chemistry · 55d
Cleared Jun 16, 1997
TOTAL THROXINE MICROPLATE EIA(225-300)
K971709 · KLI
Monobind
Chemistry · 39d
Cleared Jun 16, 1997
TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA
K971779 · CDP
Monobind
Chemistry · 33d
Cleared Jun 16, 1997
ACTIVE TESTOSTERONE EIA (DSL-10-4000)
K971823 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 31d
Cleared Jun 16, 1997
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
K971902 · LBS
Roche Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Jun 16, 1997
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)
K971952 · JJY
Bio-Rad
Chemistry · 19d
Cleared Jun 16, 1997
ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
K972004 · CGZ
Alko Diagnostic Corp.
Chemistry · 17d
Cleared Jun 13, 1997
LXN FRUCTOSAMINE TEST SYSTEM
K962597 · LCP
Lxn Corp.
Chemistry · 346d
Cleared Jun 11, 1997
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
K971505 · CHH
Beckman Instruments, Inc.
Chemistry · 47d
Cleared Jun 11, 1997
OLYMPUS CK-MB REAGENT
K971817 · JLB
Olympus America, Inc.
Chemistry · 26d
Cleared Jun 11, 1997
ACCUTEST HCG-URINE
K971886 · JHI
Unotech Diagnostics, Inc.
Chemistry · 20d
Cleared Jun 11, 1997
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)
K971954 · JJY
Bio-Rad
Chemistry · 14d