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FDA 510(k)

LDH ULTRAZYME PLUS

K-Number: K770613 · 1977-06-17

ApplicantHarleco Diagnostics
Decision Date1977-06-17
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LDH ULTRAZYME PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Harleco Diagnostics. It received FDA 510(k) clearance on 1977-06-17 under 510(k) number K770613. 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 LDH ULTRAZYME PLUS?

LDH ULTRAZYME PLUS is a medical device that received FDA 510(k) clearance on 1977-06-17. The listed applicant is Harleco Diagnostics. The 510(k) number is K770613.

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

LDH ULTRAZYME PLUS received FDA 510(k) clearance on 1977-06-17, under 510(k) number K770613.

Who is the listed applicant for LDH ULTRAZYME PLUS?

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 LDH ULTRAZYME PLUS?

The FDA product code for LDH ULTRAZYME PLUS is CFJ.

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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: 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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