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FDA 510(k)

LACTIC DEHYDROGENASE REAGENT SET

K-Number: K855159 · 1986-01-14

ApplicantTechnostics Intl.
Decision Date1986-01-14
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LACTIC DEHYDROGENASE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Technostics Intl.. It received FDA 510(k) clearance on 1986-01-14 under 510(k) number K855159. 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 LACTIC DEHYDROGENASE REAGENT SET?

LACTIC DEHYDROGENASE REAGENT SET is a medical device that received FDA 510(k) clearance on 1986-01-14. The listed applicant is Technostics Intl.. The 510(k) number is K855159.

When did LACTIC DEHYDROGENASE REAGENT SET receive FDA 510(k) clearance?

LACTIC DEHYDROGENASE REAGENT SET received FDA 510(k) clearance on 1986-01-14, under 510(k) number K855159.

Who is the listed applicant for LACTIC DEHYDROGENASE REAGENT SET?

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

What is the FDA product code for LACTIC DEHYDROGENASE REAGENT SET?

The FDA product code for LACTIC DEHYDROGENASE REAGENT SET is CFJ.

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Other records listing Technostics Intl. 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.

K855188CPK (UV) REAGENT KITK860111URIC ACID REAGENT SETK855190MAGNESIUM REAGENT SETK860110GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SETK860109ENZYMATIC UREA NITROGEN REAGENT SETK860112TOTAL LIPIDS REAGENT SET

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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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