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FDA 510(k)

IMACK-MB TEST PROCEDURE (MODIFICATION)

K-Number: K874545 · 1987-12-18

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1987-12-18
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMACK-MB TEST PROCEDURE (MODIFICATION) 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 1987-12-18 under 510(k) number K874545. 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 IMACK-MB TEST PROCEDURE (MODIFICATION)?

IMACK-MB TEST PROCEDURE (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1987-12-18. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K874545.

When did IMACK-MB TEST PROCEDURE (MODIFICATION) receive FDA 510(k) clearance?

IMACK-MB TEST PROCEDURE (MODIFICATION) received FDA 510(k) clearance on 1987-12-18, under 510(k) number K874545.

Who is the listed applicant for IMACK-MB TEST PROCEDURE (MODIFICATION)?

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 TEST PROCEDURE (MODIFICATION)?

The FDA product code for IMACK-MB TEST PROCEDURE (MODIFICATION) is JHY.

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Other records listing Intl. Immunoassay Laboratories, Inc. as applicant

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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: 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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