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FDA 510(k)

ESKACHEM, CK-MB REAGENT

K-Number: K792023 · 1979-10-30

ApplicantSmithkline Diagnostics, Inc.
Decision Date1979-10-30
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESKACHEM, CK-MB REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-10-30 under 510(k) number K792023. 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 ESKACHEM, CK-MB REAGENT?

ESKACHEM, CK-MB REAGENT is a medical device that received FDA 510(k) clearance on 1979-10-30. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K792023.

When did ESKACHEM, CK-MB REAGENT receive FDA 510(k) clearance?

ESKACHEM, CK-MB REAGENT received FDA 510(k) clearance on 1979-10-30, under 510(k) number K792023.

Who is the listed applicant for ESKACHEM, CK-MB REAGENT?

The FDA 510(k) record lists Smithkline Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESKACHEM, CK-MB REAGENT?

The FDA product code for ESKACHEM, CK-MB REAGENT is JHS.

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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.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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