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
3961–3984 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 22, 1998
OPTICOAT T3 EIA KIT
K981824 · CDP
Biotecx Laboratories, Inc.
Chemistry · 214d
Cleared Dec 22, 1998
CROSSLAPS ELISA
K972788 · JMM
Devices and Diagnostics Consulting Group
Chemistry · 512d
Cleared Dec 21, 1998
SYNCHRON SYSTEMS LIPID CALIBRATOR
K983640 · JIS
Beckman Coulter, Inc.
Chemistry · 66d
Cleared Dec 17, 1998
CARESIDE CALCIUM, ORIGINAL
K983789 · CJY
Careside, Inc.
Chemistry · 51d
Cleared Dec 17, 1998
FASTTAKE ADAPTER, MODEL # P/N 020-072-01
K983468 · JQP
Selfcare, Inc.
Chemistry · 77d
Cleared Dec 17, 1998
SUPREME II CONTROL SOLUTIONS
K983432 · JJX
Chronimed, Inc.
Chemistry · 79d
Cleared Dec 15, 1998
ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05
K984324 · JJX
Bio-Rad
Chemistry · 12d
Cleared Dec 15, 1998
ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05
K984323 · JJX
Bio-Rad
Chemistry · 12d
Cleared Dec 15, 1998
ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05
K984318 · JJX
Bio-Rad
Chemistry · 12d
Cleared Dec 14, 1998
ELECSYS CALCHECK TROPONIN T
K984372 · JJY
Boehringer Mannheim Corp.
Chemistry · 7d
Cleared Dec 14, 1998
LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384
K984225 · JJY
Bio-Rad
Chemistry · 19d
Cleared Dec 14, 1998
DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR
K984193 · JIT
Dade Behring, Inc.
Chemistry · 21d
Cleared Dec 14, 1998
STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK
K984093 · MMI
Dade Behring, Inc.
Chemistry · 28d
Cleared Dec 11, 1998
AVL OPTI CRITICAL CARE ANALYZER
K984299 · JFP
Avl Scientific Corp.
Chemistry · 10d
Cleared Dec 10, 1998
AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM
K982076 · CGA
Amira Medical, Inc.
Chemistry · 181d
Cleared Dec 09, 1998
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
K984277 · JJT
Medical Analysis Systems, Inc.
Chemistry · 9d
Cleared Dec 08, 1998
ELECSYS TROPONIN T STAT TEST
K984105 · MMI
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Dec 08, 1998
PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER...
K982303 · CGA
Medisense, Inc.
Chemistry · 160d
Cleared Dec 07, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS
K984011 · JJX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Dec 07, 1998
IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15
K983972 · MMI
Diagnostic Products Corp.
Chemistry · 28d
Cleared Dec 07, 1998
BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY
K983345 · JJE
Bayer Corp.
Chemistry · 75d
Cleared Dec 03, 1998
LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644
K984071 · JJX
Bio-Rad
Chemistry · 17d
Cleared Dec 01, 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS...
K983503 · CEO
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Dec 01, 1998
ABBOTT ARCHEITECT TOTAL B-HCG
K983424 · DHA
Abbott Laboratories
Chemistry · 63d