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FDA 510(k)

IMACK-MB(TM)

K-Number: K872592 · 1987-07-31

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1987-07-31
Product CodeJHT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMACK-MB(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Immunoassay Laboratories, Inc.. It received FDA 510(k) clearance on 1987-07-31 under 510(k) number K872592. 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 IMACK-MB(TM)?

IMACK-MB(TM) is a medical device that received FDA 510(k) clearance on 1987-07-31. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K872592.

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

IMACK-MB(TM) received FDA 510(k) clearance on 1987-07-31, under 510(k) number K872592.

Who is the listed applicant for IMACK-MB(TM)?

The FDA 510(k) record lists Intl. Immunoassay Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMACK-MB(TM)?

The FDA product code for IMACK-MB(TM) is JHT.

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Other records listing Intl. Immunoassay Laboratories, 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.

K913380MYDAS(TM)-MB2/MYDAS(TM)-MBK913349STAMBI-CKK912231PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KITK903441MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTSK903508LABELLING CHANGES TO IMPRES-MB-XK901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB

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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 LaboratoriesK904721DSL CK-MB (DSL #3200)Diagnostic Systems Laboratories, Inc.K904866COULTER CK-MB ISOENZYME REAGENTCoulter Electronics, 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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