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
4969–4992 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 02, 1996
NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4
K955252 · JJY
Nova Biomedical Corp.
Chemistry · 79d
Cleared Feb 02, 1996
NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION
K955260 · JJY
Nova Biomedical Corp.
Chemistry · 79d
Cleared Feb 02, 1996
NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2
K955264 · JJY
Nova Biomedical Corp.
Chemistry · 79d
Cleared Feb 01, 1996
NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT
K950481 · JIA
Isolab, Inc.
Chemistry · 363d
Cleared Jan 31, 1996
OLYMPUS URIC ACID REAGENT
K955752 · CDO
Olympus America, Inc.
Chemistry · 43d
Cleared Jan 29, 1996
IL TEST ACID PHOSPHATASE
K943366 · CKB
Instrumentation Laboratory CO
Chemistry · 565d
Cleared Jan 29, 1996
ACCESS FOLATE ASSAY (MODIFICATION)
K955434 · CGN
Beckman Coulter, Inc.
Chemistry · 119d
Cleared Jan 29, 1996
URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)
K955438 · JIR
Teco Diagnostics
Chemistry · 82d
Cleared Jan 26, 1996
PHENYLALANINE TEST KIT
K943547 · JNB
Isolab, Inc.
Chemistry · 554d
Cleared Jan 25, 1996
ROCHE COBAS INTEGRA REAGENT CASSETTES
K954992 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Jan 25, 1996
OPUS TROPONIN I
K955284 · MMI
Behring Diagnostics, Inc.
Chemistry · 70d
Cleared Jan 24, 1996
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS
K952557 · CDP
Sigma Diagnostics, Inc.
Chemistry · 236d
Cleared Jan 24, 1996
RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K954332 · CGN
Bayer Corp.
Chemistry · 128d
Cleared Jan 24, 1996
ACCESS TOTAL T3 ASSAY (MODIFICATION)
K955435 · CDP
Bio-Rad Laboratories, Inc.
Chemistry · 114d
Cleared Jan 24, 1996
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
K955436 · CDD
Bio-Rad Laboratories, Inc.
Chemistry · 114d
Cleared Jan 05, 1996
PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM
K953077 · CDF
Beckman Instruments, Inc.
Chemistry · 189d
Cleared Jan 05, 1996
ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV
K954839 · CIT
Sigma Diagnostics, Inc.
Chemistry · 77d
Cleared Dec 29, 1995
PYRILINKS-D ASSAY KIT
K952320 · JMM
Metra Biosystems, Inc.
Chemistry · 225d
Cleared Dec 29, 1995
INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY
K955390 · CFL
Corning Nichols Diagnostics
Chemistry · 35d
Cleared Dec 28, 1995
BLOOD GAS MIXTURE
K954546 · JIS
Liquid Technology Corp.
Chemistry · 90d
Cleared Dec 26, 1995
CK-MB (NAC-ACT)
K951223 · CGS
Randox Laboratories, Ltd.
Chemistry · 281d
Cleared Dec 26, 1995
CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
K954608 · DKB
Boehringer Mannheim Corp.
Chemistry · 83d
Cleared Dec 26, 1995
EUROTROL GAS - ISE CONTROL
K955340 · JJS
Direct Solutions
Chemistry · 36d
Cleared Dec 21, 1995
MIT ONE STEP PREGNANCY TEST
K953486 · JHI
3c Diagnostics, Inc.
Chemistry · 149d