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FDA 510(k)

CK-MB

K-Number: K771497 · 1977-08-22

ApplicantBoehringer Mannheim Corp.
Decision Date1977-08-22
Product CodeJHT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK-MB is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1977-08-22 under 510(k) number K771497. The device is classified under product code JHT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CK-MB?

CK-MB is a medical device that received FDA 510(k) clearance on 1977-08-22. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K771497.

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

CK-MB received FDA 510(k) clearance on 1977-08-22, under 510(k) number K771497.

Who is the listed applicant for CK-MB?

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

What is the FDA product code for CK-MB?

The FDA product code for CK-MB is JHT.

Other records listing Boehringer Mannheim 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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Related Devices (Code: JHT)

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.

K022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTSpectral Diagnostics, Inc.K991299MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBIPrinceton BioMeditech Corp.K930359CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305Helena LaboratoriesK904866COULTER CK-MB ISOENZYME REAGENTCoulter Electronics, Inc.K904721DSL CK-MB (DSL #3200)Diagnostic Systems Laboratories, Inc.K901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MBIntl. Immunoassay Laboratories, 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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