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FDA 510(k)

CK-MB (CREATINE KINASE-MB) RIA CONTROL

K-Number: K792524 · 1980-01-16

ApplicantMallinckrodt Critical Care
Decision Date1980-01-16
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK-MB (CREATINE KINASE-MB) RIA CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1980-01-16 under 510(k) number K792524. 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 CK-MB (CREATINE KINASE-MB) RIA CONTROL?

CK-MB (CREATINE KINASE-MB) RIA CONTROL is a medical device that received FDA 510(k) clearance on 1980-01-16. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K792524.

When did CK-MB (CREATINE KINASE-MB) RIA CONTROL receive FDA 510(k) clearance?

CK-MB (CREATINE KINASE-MB) RIA CONTROL received FDA 510(k) clearance on 1980-01-16, under 510(k) number K792524.

Who is the listed applicant for CK-MB (CREATINE KINASE-MB) RIA CONTROL?

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

What is the FDA product code for CK-MB (CREATINE KINASE-MB) RIA CONTROL?

The FDA product code for CK-MB (CREATINE KINASE-MB) RIA CONTROL is 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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