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FDA 510(k)

GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH

K-Number: K772028 · 1977-11-15

ApplicantHarleco
Decision Date1977-11-15
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-11-15 under 510(k) number K772028. The device is classified under product code CFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH?

GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH is a medical device that received FDA 510(k) clearance on 1977-11-15. The listed applicant is Harleco. The 510(k) number is K772028.

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

GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH received FDA 510(k) clearance on 1977-11-15, under 510(k) number K772028.

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

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 LDH?

The FDA product code for GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH is CFJ.

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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: CFJ)

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.

K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K091544S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017Alfa Wassermann, Inc.K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.K974859LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30Diagnostic Chemicals , Ltd.K973589LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,K970684LACTATE DEHYDROGENASE (LD)Randox Laboratories, Ltd.

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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