Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Spectral Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K052519 SPECTRAL WEST NILE VIRUS IGM STATUS TESTNOP2006-11-30 View
510(k) K030057 SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TESTMMI2003-03-19 View
510(k) K022409 SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTJHT2002-09-30 View
510(k) K020950 SPECTRAL'S 2 IN 1 (TNI-MYO)MMI2002-05-24 View
510(k) K014105 SPECTRAL'S TROPONIN IMMI2002-02-01 View
510(k) K992127 CARDIOQUANT TROPONIN I TESTMMI1999-10-04 View
510(k) K991447 CARDIOQUANT CARDIAC ASSESSMENT CONTROLSJJY1999-06-11 View
510(k) K982679 MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TESTDDR1998-10-07 View
510(k) K981474 CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)JJY1998-05-07 View
510(k) K972687 CARDIAC STATUS CONTROLS/TROPONIN IJJX1997-07-28 View
510(k) K972408 CARDIAC STATUS CONTROLSJJT1997-07-25 View
↑