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FDA 510(k)

IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225

K-Number: K881351 · 1988-06-01

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1988-06-01
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 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 1988-06-01 under 510(k) number K881351. 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, CATALOGS 602-1, 602-1/125, 602-1/225?

IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 is a medical device that received FDA 510(k) clearance on 1988-06-01. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K881351.

When did IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 receive FDA 510(k) clearance?

IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 received FDA 510(k) clearance on 1988-06-01, under 510(k) number K881351.

Who is the listed applicant for IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225?

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, CATALOGS 602-1, 602-1/125, 602-1/225?

The FDA product code for IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 is JHY.

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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: 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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