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FDA 510(k)

BIOTROL LACTATE DEHYDROGENASE (L-P)

K-Number: K905683 · 1991-03-11

ApplicantBiotrol, USA, Inc.
Decision Date1991-03-11
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL LACTATE DEHYDROGENASE (L-P) is the device name listed in this FDA 510(k) record. The listed applicant is Biotrol, USA, Inc.. It received FDA 510(k) clearance on 1991-03-11 under 510(k) number K905683. 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 BIOTROL LACTATE DEHYDROGENASE (L-P)?

BIOTROL LACTATE DEHYDROGENASE (L-P) is a medical device that received FDA 510(k) clearance on 1991-03-11. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K905683.

When did BIOTROL LACTATE DEHYDROGENASE (L-P) receive FDA 510(k) clearance?

BIOTROL LACTATE DEHYDROGENASE (L-P) received FDA 510(k) clearance on 1991-03-11, under 510(k) number K905683.

Who is the listed applicant for BIOTROL LACTATE DEHYDROGENASE (L-P)?

The FDA 510(k) record lists Biotrol, USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOTROL LACTATE DEHYDROGENASE (L-P)?

The FDA product code for BIOTROL LACTATE DEHYDROGENASE (L-P) is CFJ.

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Other records listing Biotrol, USA, Inc. 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.

K934014VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANTK931141BIOTROL AMYLASE CNPG3K921855BIOTROL BICARBONATE STANDARDSK921677BIOTROL MAGNESIUM (MAGON)K912795BIOTROL UIBC REAGENTK910721BIOTROL PROTEIN MULTILEVEL STANDARDS

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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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