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FDA 510(k)

ULTRAZYME PLUS GAMMA GT(65055-65056)

K-Number: K820233 · 1982-02-12

ApplicantHarleco
Decision Date1982-02-12
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRAZYME PLUS GAMMA GT(65055-65056) is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1982-02-12 under 510(k) number K820233. The device is classified under product code JQB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAZYME PLUS GAMMA GT(65055-65056)?

ULTRAZYME PLUS GAMMA GT(65055-65056) is a medical device that received FDA 510(k) clearance on 1982-02-12. The listed applicant is Harleco. The 510(k) number is K820233.

When did ULTRAZYME PLUS GAMMA GT(65055-65056) receive FDA 510(k) clearance?

ULTRAZYME PLUS GAMMA GT(65055-65056) received FDA 510(k) clearance on 1982-02-12, under 510(k) number K820233.

Who is the listed applicant for ULTRAZYME PLUS GAMMA GT(65055-65056)?

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 ULTRAZYME PLUS GAMMA GT(65055-65056)?

The FDA product code for ULTRAZYME PLUS GAMMA GT(65055-65056) is JQB.

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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.

K813427ULTRACHEM GLUC-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813041ULTRAZYME-GT, ITEM #64959 & 65032K813038ULTRACHEM TP, ITEM #64974K813043ULTRACHEM CREA ITEM #64972

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Related Devices (Code: JQB)

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.

K974000Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30Diagnostic Chemicals , Ltd.K973157LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SETPointe Scientific, Inc.,K971466SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)Carolina Liquid Chemistries Corp.K964457ROCHE COBAS IBTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc.K964916GAMMA-GLUTAMYL TRANSPEPTIDASEDerma Media Lab., Inc.K955770GAMMA GLUTAMYL TRANSFERASE TEST SYSTEMAbaxis, 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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