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FDA 510(k)

CKMB UDR ASSAY

K-Number: K102706 · 2011-08-19

ApplicantSENTINEL CH. SpA
Decision Date2011-08-19
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CKMB UDR ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is SENTINEL CH. SpA. It received FDA 510(k) clearance on 2011-08-19 under 510(k) number K102706. 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 CKMB UDR ASSAY?

CKMB UDR ASSAY is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is SENTINEL CH. SpA. The 510(k) number is K102706.

When did CKMB UDR ASSAY receive FDA 510(k) clearance?

CKMB UDR ASSAY received FDA 510(k) clearance on 2011-08-19, under 510(k) number K102706.

Who is the listed applicant for CKMB UDR ASSAY?

The FDA 510(k) record lists SENTINEL CH. SpA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CKMB UDR ASSAY?

The FDA product code for CKMB UDR ASSAY is JHS.

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Other records listing SENTINEL CH. SpA as applicant

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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)K082226S40 CREATINE KINASE (CK)Alfa Wassermann Diagnostic Technologies, Inc.K062128THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYSDade Behring, Inc.K990434CARESIDE CKMBCareside, Inc.K990439CARESIDE CKCareside, Inc.K981495IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)Diagnostic Products Corp.

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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