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FDA 510(k)

CARDIOZYME PLUS CK-TOTAL #65046

K-Number: K803169 · 1981-01-09

ApplicantHarleco
Decision Date1981-01-09
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIOZYME PLUS CK-TOTAL #65046 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1981-01-09 under 510(k) number K803169. 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 CARDIOZYME PLUS CK-TOTAL #65046?

CARDIOZYME PLUS CK-TOTAL #65046 is a medical device that received FDA 510(k) clearance on 1981-01-09. The listed applicant is Harleco. The 510(k) number is K803169.

When did CARDIOZYME PLUS CK-TOTAL #65046 receive FDA 510(k) clearance?

CARDIOZYME PLUS CK-TOTAL #65046 received FDA 510(k) clearance on 1981-01-09, under 510(k) number K803169.

Who is the listed applicant for CARDIOZYME PLUS CK-TOTAL #65046?

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

What is the FDA product code for CARDIOZYME PLUS CK-TOTAL #65046?

The FDA product code for CARDIOZYME PLUS CK-TOTAL #65046 is JHS.

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Other records listing Harleco 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.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032

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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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