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FDA 510(k)

CREATINE KINASE-MB KIT

K-Number: K820812 · 1982-04-12

ApplicantCalbiochem-Behring Corp.
Decision Date1982-04-12
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE-MB KIT is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1982-04-12 under 510(k) number K820812. The device is classified under product code JHY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATINE KINASE-MB KIT?

CREATINE KINASE-MB KIT is a medical device that received FDA 510(k) clearance on 1982-04-12. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K820812.

When did CREATINE KINASE-MB KIT receive FDA 510(k) clearance?

CREATINE KINASE-MB KIT received FDA 510(k) clearance on 1982-04-12, under 510(k) number K820812.

Who is the listed applicant for CREATINE KINASE-MB KIT?

The FDA 510(k) record lists Calbiochem-Behring Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREATINE KINASE-MB KIT?

The FDA product code for CREATINE KINASE-MB KIT is JHY.

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Other records listing Calbiochem-Behring Corp. 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.

K831811REVOLUTION RADIAL IMMUNODIFFUSION PLATEK831036ENA TEST KIT SM & RNP AUTO ANTIBODYK830214AFT SYSTEM IIIK813493ENZYGNOST TM RUBELLA IGMK820088AFT SYSTEM PROFICIENCY TESTING PROGRAMK812458PADAC

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Related Devices (Code: JHY)

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.

K132571ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAYRoche DiagnosticsK070835OLYMPUS CK-MB REAGENTOlympus Life & Material Science Europa GmbH (IrishK022757SPIFE CK KIT, MODEL 3332, 3333Helena LaboratoriesK022654MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MBRoche Diagnostics Corp.K974421ELECSYS CK-MB STATBoehringer Mannheim Corp.K970343MMB METHODDade Chemistry Systems, Inc.

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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