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

154 results for "Siemens Healthcare Diagnostics, Inc."
145–154 of 154
Search insights Median review: 92d Cleared: 99% Top manufacturer: Siemens Healthcare Diagnostics, Inc. Lead specialty: Chemistry
Cleared Sep 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
K081789 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 77d
Cleared Aug 22, 2008
DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
K082030 · DLJ
Siemens Healthcare Diagnostics, Inc.
Toxicology · 36d
Cleared Aug 08, 2008
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM...
K081299 · DDG
Siemens Healthcare Diagnostics, Inc.
Immunology · 92d
Cleared Aug 05, 2008
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
K081992 · MKW
Siemens Healthcare Diagnostics, Inc.
Toxicology · 22d
Cleared Aug 04, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
K081319 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 84d
Cleared Jul 29, 2008
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP),...
K081294 · NQD
Siemens Healthcare Diagnostics, Inc.
Chemistry · 83d
Cleared Jul 17, 2008
ADVIA CENTAUR HAVM ASSAY
K081716 · LOL
Siemens Healthcare Diagnostics, Inc.
Microbiology · 29d
Cleared May 23, 2008
LOCI THYROID CALIBRATOR WITH MODEL RC610
K081103 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared May 23, 2008
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF...
K081074 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared May 16, 2008
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT...
K080578 · NBC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 74d