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FDA 510(k)

CHECK-MM

K-Number: K883223 · 1988-09-30

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1988-09-30
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHECK-MM 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 1988-09-30 under 510(k) number K883223. 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 CHECK-MM?

CHECK-MM is a medical device that received FDA 510(k) clearance on 1988-09-30. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K883223.

When did CHECK-MM receive FDA 510(k) clearance?

CHECK-MM received FDA 510(k) clearance on 1988-09-30, under 510(k) number K883223.

Who is the listed applicant for CHECK-MM?

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 CHECK-MM?

The FDA product code for CHECK-MM is JHS.

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

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Related Devices (Code: JHS)

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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.K990434CARESIDE CKMBCareside, Inc.K990439CARESIDE CKCareside, 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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