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FDA 510(k)

GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT

K-Number: K772030 · 1977-11-14

ApplicantHarleco
Decision Date1977-11-14
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-11-14 under 510(k) number K772030. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT?

GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT is a medical device that received FDA 510(k) clearance on 1977-11-14. The listed applicant is Harleco. The 510(k) number is K772030.

When did GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT receive FDA 510(k) clearance?

GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT received FDA 510(k) clearance on 1977-11-14, under 510(k) number K772030.

Who is the listed applicant for GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT?

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 GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT?

The FDA product code for GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT is CKA.

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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-DHK813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813044ULTRACHEM ALB, ITEM #64970

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Related Devices (Code: CKA)

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.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, 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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