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FDA 510(k)

ULTRA ZYME PLUS LDH #64950, 65038 & 39

K-Number: K812590 · 1981-09-24

ApplicantHarleco
Decision Date1981-09-24
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRA ZYME PLUS LDH #64950, 65038 & 39 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1981-09-24 under 510(k) number K812590. 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 ULTRA ZYME PLUS LDH #64950, 65038 & 39?

ULTRA ZYME PLUS LDH #64950, 65038 & 39 is a medical device that received FDA 510(k) clearance on 1981-09-24. The listed applicant is Harleco. The 510(k) number is K812590.

When did ULTRA ZYME PLUS LDH #64950, 65038 & 39 receive FDA 510(k) clearance?

ULTRA ZYME PLUS LDH #64950, 65038 & 39 received FDA 510(k) clearance on 1981-09-24, under 510(k) number K812590.

Who is the listed applicant for ULTRA ZYME PLUS LDH #64950, 65038 & 39?

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 ULTRA ZYME PLUS LDH #64950, 65038 & 39?

The FDA product code for ULTRA ZYME PLUS LDH #64950, 65038 & 39 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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