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FDA 510(k)

BIOTROL URIC ACID ENZYMATIQUE UV H.P.

K-Number: K875320 · 1988-02-01

ApplicantBiotrol, USA, Inc.
Decision Date1988-02-01
Product CodeCDO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL URIC ACID ENZYMATIQUE UV H.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 1988-02-01 under 510(k) number K875320. The device is classified under product code CDO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTROL URIC ACID ENZYMATIQUE UV H.P.?

BIOTROL URIC ACID ENZYMATIQUE UV H.P. is a medical device that received FDA 510(k) clearance on 1988-02-01. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K875320.

When did BIOTROL URIC ACID ENZYMATIQUE UV H.P. receive FDA 510(k) clearance?

BIOTROL URIC ACID ENZYMATIQUE UV H.P. received FDA 510(k) clearance on 1988-02-01, under 510(k) number K875320.

Who is the listed applicant for BIOTROL URIC ACID ENZYMATIQUE UV H.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 URIC ACID ENZYMATIQUE UV H.P.?

The FDA product code for BIOTROL URIC ACID ENZYMATIQUE UV H.P. is CDO.

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Other records listing Biotrol, USA, Inc. as applicant

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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: CDO)

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.

K033278RANDOX URIC ACIDRandox Laboratories, Ltd.K992798SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100PSigma Diagnostics, Inc.K982251SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KITSigma Diagnostics, Inc.K981766URIC ACIDAbbott LaboratoriesK981189URIC ACIDAbbott LaboratoriesK971485URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.

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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