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FDA 510(k)

DATA-ZYME CK CALORIMETRIC/UV PROCEDURE

K-Number: K790343 · 1979-05-01

ApplicantData Medical Associates, Inc.
Decision Date1979-05-01
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DATA-ZYME CK CALORIMETRIC/UV PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1979-05-01 under 510(k) number K790343. 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 DATA-ZYME CK CALORIMETRIC/UV PROCEDURE?

DATA-ZYME CK CALORIMETRIC/UV PROCEDURE is a medical device that received FDA 510(k) clearance on 1979-05-01. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K790343.

When did DATA-ZYME CK CALORIMETRIC/UV PROCEDURE receive FDA 510(k) clearance?

DATA-ZYME CK CALORIMETRIC/UV PROCEDURE received FDA 510(k) clearance on 1979-05-01, under 510(k) number K790343.

Who is the listed applicant for DATA-ZYME CK CALORIMETRIC/UV PROCEDURE?

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

What is the FDA product code for DATA-ZYME CK CALORIMETRIC/UV PROCEDURE?

The FDA product code for DATA-ZYME CK CALORIMETRIC/UV PROCEDURE is JHS.

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Other records listing Data Medical Associates, Inc. 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)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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