FDA 510(k)

CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3

K-Number: K982845 · 1998-08-21

Decision Date1998-08-21

Product CodeJJT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 is the device name listed in this FDA 510(k) record. The listed applicant is More Diagnostics. It received FDA 510(k) clearance on 1998-08-21 under 510(k) number K982845. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3?

CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 is a medical device that received FDA 510(k) clearance on 1998-08-21. The listed applicant is More Diagnostics. The 510(k) number is K982845.

When did CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 receive FDA 510(k) clearance?

CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 received FDA 510(k) clearance on 1998-08-21, under 510(k) number K982845.

Who is the listed applicant for CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3?

The FDA 510(k) record lists More Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3?

The FDA product code for CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 is JJT.

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Related Devices (Code: JJT)

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Official Source

View on FDA Database →

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