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FDA 510(k)

LD-P REAGENT (LDH P-L REAGENT)

K-Number: K790771 · 1979-05-15

ApplicantGilford Diagnostics
Decision Date1979-05-15
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LD-P REAGENT (LDH P-L REAGENT) is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1979-05-15 under 510(k) number K790771. 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 LD-P REAGENT (LDH P-L REAGENT)?

LD-P REAGENT (LDH P-L REAGENT) is a medical device that received FDA 510(k) clearance on 1979-05-15. The listed applicant is Gilford Diagnostics. The 510(k) number is K790771.

When did LD-P REAGENT (LDH P-L REAGENT) receive FDA 510(k) clearance?

LD-P REAGENT (LDH P-L REAGENT) received FDA 510(k) clearance on 1979-05-15, under 510(k) number K790771.

Who is the listed applicant for LD-P REAGENT (LDH P-L REAGENT)?

The FDA 510(k) record lists Gilford Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LD-P REAGENT (LDH P-L REAGENT)?

The FDA product code for LD-P REAGENT (LDH P-L REAGENT) is CFJ.

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Other records listing Gilford 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.

K832094BILIRUBIN CALIBRATORS & CONTROLK831844DIRECT BILIRUBIN REAGENTK831843GILCHEM TOTAL BILIRUBIN REAGENTK823709TRIGLYCERIDE REAGENT (UV)K822739AHBDK822334BILIRUBIN CALIBRATORS

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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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