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510(k) K972687

CARDIAC STATUS CONTROLS/TROPONIN I by Spectral Diagnostics, Inc. — Product Code JJX

K972687 is an FDA 510(k) premarket notification submitted by Spectral Diagnostics, Inc. for the device "CARDIAC STATUS CONTROLS/TROPONIN I". The FDA issued a decision of Substantially Equivalent on July 28, 1997. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Spectral Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1997
Date Received
July 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Spectral Diagnostics, Inc.

  • K052519 — SPECTRAL WEST NILE VIRUS IGM STATUS TEST (November 30, 2006)
  • DEN030002 — ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE (June 16, 2003)
  • K030057 — SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST (March 19, 2003)
  • K022409 — SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST (September 30, 2002)
  • K020950 — SPECTRAL'S 2 IN 1 (TNI-MYO) (May 24, 2002)
  • K014105 — SPECTRAL'S TROPONIN I (February 1, 2002)
  • K992127 — CARDIOQUANT TROPONIN I TEST (October 4, 1999)
  • K991447 — CARDIOQUANT CARDIAC ASSESSMENT CONTROLS (June 11, 1999)
  • K982679 — MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST (October 7, 1998)
  • K981474 — CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) (May 7, 1998)

Other clearances for product code JJX

  • K170678 — Beta-CrossLaps CalCheck 5 (April 4, 2017)
  • K162173 — Elecsys CYFRA 21-1 CalCheck 5 (January 12, 2017)
  • K162514 — Multichem A1c (October 26, 2016)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K161526 — LIAISON CMV IgM Serum Control Set (June 30, 2016)
  • K161522 — LIAISON EBV IgM Serum Control Set (June 30, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K152117 — Dropper hsCRP High Sensitivity CRP Control (April 21, 2016)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Ce (July 17, 2015)

FDA data resources