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FDA 510(k)

CARDIO ZYME PLUS CK-MB #65045

K-Number: K803168 · 1981-01-09

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

Device Summary

CARDIO ZYME PLUS CK-MB #65045 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 K803168. The device is classified under product code JHW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO ZYME PLUS CK-MB #65045?

CARDIO ZYME PLUS CK-MB #65045 is a medical device that received FDA 510(k) clearance on 1981-01-09. The listed applicant is Harleco. The 510(k) number is K803168.

When did CARDIO ZYME PLUS CK-MB #65045 receive FDA 510(k) clearance?

CARDIO ZYME PLUS CK-MB #65045 received FDA 510(k) clearance on 1981-01-09, under 510(k) number K803168.

Who is the listed applicant for CARDIO ZYME PLUS CK-MB #65045?

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 CARDIO ZYME PLUS CK-MB #65045?

The FDA product code for CARDIO ZYME PLUS CK-MB #65045 is JHW.

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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: JHW)

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.

K162526Creatine Kinase-MBRoche DiagnosticsK122083ELITECH CLINICAL SYSTEMS CK NAC SLElitechgroupK023744WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354Wiener Laboratories SaicK003158ROCHE DIAGNOSTICS CK-MBRoche Diagnostics Corp.K961501ELECSYS CK-MBBoehringer Mannheim Corp.K950186CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMMiles, 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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