Spectral Diagnostics, In… - 11 FDA 510(k) Chemistry Devices (Since 1997)

Spectral Diagnostics, Inc. — FDA 510(k) Submissions

Spectral Diagnostics, Inc. has submitted 12 FDA 510(k) premarket notifications since 1997, of which 11 received clearance as substantially equivalent to a predicate device.

SPECTRAL WEST NILE VIRUS IGM STATUS TEST

K052519 · NOP Elisa, Antibody, West Nile Virus · Microbiology

Nov 2006 442d

ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE

DEN030002 · NGS Assay, Endotoxin Activity, Chemiluminescent · Microbiology

Jun 2003 63d

SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST

K030057 · MMI Immunoassay Method, Troponin Subunit · Chemistry

Mar 2003 71d

SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST

K022409 · JHT Chromatographic Separation, Cpk Isoenzymes · Chemistry

Sep 2002 68d

SPECTRAL'S 2 IN 1 (TNI-MYO)

K020950 · MMI Immunoassay Method, Troponin Subunit · Chemistry

May 2002 60d

SPECTRAL'S TROPONIN I

K014105 · MMI Immunoassay Method, Troponin Subunit · Chemistry

Feb 2002 50d

CARDIOQUANT TROPONIN I TEST

K992127 · MMI Immunoassay Method, Troponin Subunit · Chemistry

Oct 1999 103d

CARDIOQUANT CARDIAC ASSESSMENT CONTROLS

K991447 · JJY Multi-analyte Controls, All Kinds (assayed) · Chemistry

Jun 1999 46d

MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST

K982679 · DDR Myoglobin, Antigen, Antiserum, Control · Chemistry

Oct 1998 68d

CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)

K981474 · JJY Multi-analyte Controls, All Kinds (assayed) · Chemistry

May 1998 13d

CARDIAC STATUS CONTROLS/TROPONIN I

K972687 · JJX Single (specified) Analyte Controls (assayed And Unassayed) · Chemistry

Jul 1997 11d

CARDIAC STATUS CONTROLS

K972408 · JJT Enzyme Controls (assayed And Unassayed) · Chemistry

Jul 1997 29d

Spectral Diagnostics, Inc.

Spectral Diagnostics, Inc. — FDA 510(k) Submissions

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