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FDA 510(k)

MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM

K-Number: K932659 · 1993-07-28

ApplicantMore Diagnostics
Decision Date1993-07-28
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM is the device name listed in this FDA 510(k) record. The listed applicant is More Diagnostics. It received FDA 510(k) clearance on 1993-07-28 under 510(k) number K932659. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM?

MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM is a medical device that received FDA 510(k) clearance on 1993-07-28. The listed applicant is More Diagnostics. The 510(k) number is K932659.

When did MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM receive FDA 510(k) clearance?

MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM received FDA 510(k) clearance on 1993-07-28, under 510(k) number K932659.

Who is the listed applicant for MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM?

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 MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM?

The FDA product code for MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM is JJX.

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Other records listing More Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELK050125RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4K982845CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3K980331IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\SK972976CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVELK970778LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4

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Related Devices (Code: JJX)

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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.

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