FDA 510(k)

MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL

K-Number: K013995 · 2001-12-21

Decision Date2001-12-21

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL 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 2001-12-21 under 510(k) number K013995. 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 MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL?

MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL is a medical device that received FDA 510(k) clearance on 2001-12-21. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K013995.

When did MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL receive FDA 510(k) clearance?

MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL received FDA 510(k) clearance on 2001-12-21, under 510(k) number K013995.

Who is the listed applicant for MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL?

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 MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL?

The FDA product code for MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL 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.