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FDA 510(k)

CREATINE KINASE (CK) ISOENZYME MB

K-Number: K881168 · 1988-11-10

ApplicantData Medical Associates, Inc.
Decision Date1988-11-10
Product CodeJHT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE (CK) ISOENZYME MB is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1988-11-10 under 510(k) number K881168. 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 CREATINE KINASE (CK) ISOENZYME MB?

CREATINE KINASE (CK) ISOENZYME MB is a medical device that received FDA 510(k) clearance on 1988-11-10. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K881168.

When did CREATINE KINASE (CK) ISOENZYME MB receive FDA 510(k) clearance?

CREATINE KINASE (CK) ISOENZYME MB received FDA 510(k) clearance on 1988-11-10, under 510(k) number K881168.

Who is the listed applicant for CREATINE KINASE (CK) ISOENZYME MB?

The FDA 510(k) record lists Data Medical Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREATINE KINASE (CK) ISOENZYME MB?

The FDA product code for CREATINE KINASE (CK) ISOENZYME MB is JHT.

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Other records listing Data Medical Associates, Inc. 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.

K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003K971113DMA TRIGLYCERIDES PROCEDURESK961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREK955302SERUM BICARBONATE/CARBON DIOXIDEK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955300TOTAL BILIRUBIN PROCEDURE

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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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