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FDA 510(k)

CARDI-CK EIA TEST KIT CK-MB ISOENZYME

K-Number: K843007 · 1984-09-07

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1984-09-07
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDI-CK EIA TEST KIT CK-MB ISOENZYME 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 1984-09-07 under 510(k) number K843007. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDI-CK EIA TEST KIT CK-MB ISOENZYME?

CARDI-CK EIA TEST KIT CK-MB ISOENZYME is a medical device that received FDA 510(k) clearance on 1984-09-07. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K843007.

When did CARDI-CK EIA TEST KIT CK-MB ISOENZYME receive FDA 510(k) clearance?

CARDI-CK EIA TEST KIT CK-MB ISOENZYME received FDA 510(k) clearance on 1984-09-07, under 510(k) number K843007.

Who is the listed applicant for CARDI-CK EIA TEST KIT CK-MB ISOENZYME?

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 CARDI-CK EIA TEST KIT CK-MB ISOENZYME?

The FDA product code for CARDI-CK EIA TEST KIT CK-MB ISOENZYME is JHS.

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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: JHS)

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.

K160570Creatine KinaseRoche Diagnostics Operations (Rdo)K102706CKMB UDR ASSAYSENTINEL CH. SpAK082226S40 CREATINE KINASE (CK)Alfa Wassermann Diagnostic Technologies, Inc.K062128THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYSDade Behring, Inc.K990439CARESIDE CKCareside, Inc.K990434CARESIDE CKMBCareside, 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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