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FDA 510(k)

CK-MB(IMMUNOLOGICAL)

K-Number: K802521 · 1980-11-12

ApplicantBiodynamics Corp.
Decision Date1980-11-12
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK-MB(IMMUNOLOGICAL) is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamics Corp.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802521. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CK-MB(IMMUNOLOGICAL)?

CK-MB(IMMUNOLOGICAL) is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Biodynamics Corp.. The 510(k) number is K802521.

When did CK-MB(IMMUNOLOGICAL) receive FDA 510(k) clearance?

CK-MB(IMMUNOLOGICAL) received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802521.

Who is the listed applicant for CK-MB(IMMUNOLOGICAL)?

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

What is the FDA product code for CK-MB(IMMUNOLOGICAL)?

The FDA product code for CK-MB(IMMUNOLOGICAL) is JHS.

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Other records listing Biodynamics 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.

K051675BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZERK884033BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZERK881631BIODYNAMICS AUTOTRANSFUSION RESERVOIRK881968BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZERK874361BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZERK873807AUTOTRANSFUSION APPARATUS

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Related Devices (Code: JHS)

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.

K160570Creatine KinaseRoche Diagnostics Operations (Rdo)K102706CKMB UDR ASSAYSENTINEL CH. SpAK082226S40 CREATINE KINASE (CK)Alfa Wassermann Diagnostic Technologies, Inc.K062128THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYSDade Behring, Inc.K990434CARESIDE CKMBCareside, Inc.K990439CARESIDE CKCareside, 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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