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FDA 510(k)

UNI-FAST CREATINE KINASE TEST (CK)

K-Number: K872029 · 1987-06-17

ApplicantSclavo, Inc.
Decision Date1987-06-17
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNI-FAST CREATINE KINASE TEST (CK) is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1987-06-17 under 510(k) number K872029. 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 UNI-FAST CREATINE KINASE TEST (CK)?

UNI-FAST CREATINE KINASE TEST (CK) is a medical device that received FDA 510(k) clearance on 1987-06-17. The listed applicant is Sclavo, Inc.. The 510(k) number is K872029.

When did UNI-FAST CREATINE KINASE TEST (CK) receive FDA 510(k) clearance?

UNI-FAST CREATINE KINASE TEST (CK) received FDA 510(k) clearance on 1987-06-17, under 510(k) number K872029.

Who is the listed applicant for UNI-FAST CREATINE KINASE TEST (CK)?

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

What is the FDA product code for UNI-FAST CREATINE KINASE TEST (CK)?

The FDA product code for UNI-FAST CREATINE KINASE TEST (CK) is JHS.

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Other records listing Sclavo, 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.

K914789ELISA CMV IGMK914852ELISA TOXO IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)

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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.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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