FDA 510(k)

CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3

K-Number: K970976 · 1997-04-02

Decision Date1997-04-02

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1997-04-02 under 510(k) number K970976. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3?

CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K970976.

When did CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 receive FDA 510(k) clearance?

CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 received FDA 510(k) clearance on 1997-04-02, under 510(k) number K970976.

Who is the listed applicant for CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3?

The FDA 510(k) record lists Medical Analysis Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3?

The FDA product code for CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 is JJY.

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Other records listing Medical Analysis Systems, Inc. as applicant

K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL K041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H K040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 K032826MAS PAR TDM K032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL K031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.