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FDA 510(k)

ULTRAZYME PLUS 2GT

K-Number: K821871 · 1982-07-14

ApplicantHarleco Diagnostics
Decision Date1982-07-14
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRAZYME PLUS 2GT is the device name listed in this FDA 510(k) record. The listed applicant is Harleco Diagnostics. It received FDA 510(k) clearance on 1982-07-14 under 510(k) number K821871. The device is classified under product code JPZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAZYME PLUS 2GT?

ULTRAZYME PLUS 2GT is a medical device that received FDA 510(k) clearance on 1982-07-14. The listed applicant is Harleco Diagnostics. The 510(k) number is K821871.

When did ULTRAZYME PLUS 2GT receive FDA 510(k) clearance?

ULTRAZYME PLUS 2GT received FDA 510(k) clearance on 1982-07-14, under 510(k) number K821871.

Who is the listed applicant for ULTRAZYME PLUS 2GT?

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

What is the FDA product code for ULTRAZYME PLUS 2GT?

The FDA product code for ULTRAZYME PLUS 2GT is JPZ.

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Other records listing Harleco Diagnostics 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.

K823147URIC ACID STANDARD, 8MG/DL #65078K822852TRIGLYCERIDE CALIBRATORK822323ULTRACHEM BUN-UV, 65080 & 65081K821880ULTRA CHEM ALBK821877ULTRAZYME PLUS HBDK821879ULTRACHEM T.P.

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Related Devices (Code: JPZ)

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.

K020486CARESIDE GGTCareside, Inc.K961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREData Medical Associates, Inc.K923509GAMMA-GTRandox Laboratories, Ltd.K923091KING DIAGNOSTICS GAMMA GT REAGENTKing Diagnostics, Inc.K905618GGT REAGENTAmresco, Inc.K903304ROCHE COBAS READY GGT REAGENTRoche Diagnostic Systems, 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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