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
5737–5760 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 22, 1993
KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT
K933329 · JMO
King Diagnostics, Inc.
Chemistry · 106d
Cleared Oct 22, 1993
STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
K933464 · CHP
Baxter Diagnostics, Inc.
Chemistry · 98d
Cleared Oct 22, 1993
SIGMA ELECTROLYTE BUFFER
K933695 · JFL
Sigma Chemical Co.
Chemistry · 85d
Cleared Oct 22, 1993
VISTA FOLATE ASSAY
K934121 · CGN
Syva Co.
Chemistry · 58d
Cleared Oct 21, 1993
LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2
K934357 · JJY
Bio-Rad
Chemistry · 43d
Cleared Oct 18, 1993
OLYMPUS AMYLASE REAGENT
K931301 · CIJ
Olympus Corp.
Chemistry · 217d
Cleared Oct 18, 1993
CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323
K932768 · JIX
Helena Laboratories
Chemistry · 132d
Cleared Oct 18, 1993
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
K932980 · CDX
Sigma Diagnostics, Inc.
Chemistry · 123d
Cleared Oct 18, 1993
SIGMA CRE REAGENT
K933697 · CGX
Sigma Chemical Co.
Chemistry · 81d
Cleared Oct 18, 1993
TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3
K934056 · JJY
Medical Analysis Systems, Inc.
Chemistry · 60d
Cleared Oct 14, 1993
AVL 9110PH ANALYZER
K932642 · CHL
Avl Scientific Corp.
Chemistry · 134d
Cleared Oct 14, 1993
CHEMSTRIP SUPER UA URINE ANALYZER
K934042 · KQO
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Oct 14, 1993
BECKMAN HDL CHOLESTEROL REAGENT
K934045 · LBS
Beckman Instruments, Inc.
Chemistry · 56d
Cleared Oct 13, 1993
SIGMA CX-3 CALIBRATION STANDARD LEVEL 2
K933693 · JIX
Sigma Chemical Co.
Chemistry · 76d
Cleared Oct 13, 1993
DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM
K933955 · JIX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 62d
Cleared Oct 12, 1993
ACCULYTE CHEMILUMINESCENCE ANALYZER
K921536 · JJQ
Laboratory Technologies, Inc.
Chemistry · 580d
Cleared Oct 12, 1993
IL TEST GLUCOSE
K931402 · CFR
Instrumentation Laboratory CO
Chemistry · 207d
Cleared Oct 12, 1993
VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM
K933386 · GIM
Bd Becton Dickinson Vacutainer...
Chemistry · 92d
Cleared Oct 12, 1993
ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)
K933862 · JGS
Schiapparelli Biosystems, Inc.
Chemistry · 64d
Cleared Oct 08, 1993
STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY
K933635 · JLS
Baxter Diagnostics, Inc.
Chemistry · 73d
Cleared Oct 08, 1993
SIGMA CX-3 CALIBRATION STANDARD LEVEL 1
K933702 · JIX
Sigma Chemical Co.
Chemistry · 71d
Cleared Oct 01, 1993
IL TEST URIC ACID
K931350 · KNK
Instrumentation Laboratory CO
Chemistry · 198d
Cleared Oct 01, 1993
RADIAS FOLATE ENZYME IMMUNOASSAY
K933571 · CGN
Bio-Rad
Chemistry · 70d
Cleared Sep 29, 1993
ANTHOS HT READERS, INCLUDING THE ANTHOS HT II&III
K931907 · JJQ
Anthos Labtec Instruments
Chemistry · 167d