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FDA 510(k)

BIOTROL BICARBONATE STANDARDS

K-Number: K921855 · 1992-08-03

ApplicantBiotrol, USA, Inc.
Decision Date1992-08-03
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL BICARBONATE STANDARDS 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 1992-08-03 under 510(k) number K921855. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTROL BICARBONATE STANDARDS?

BIOTROL BICARBONATE STANDARDS is a medical device that received FDA 510(k) clearance on 1992-08-03. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K921855.

When did BIOTROL BICARBONATE STANDARDS receive FDA 510(k) clearance?

BIOTROL BICARBONATE STANDARDS received FDA 510(k) clearance on 1992-08-03, under 510(k) number K921855.

Who is the listed applicant for BIOTROL BICARBONATE STANDARDS?

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 BICARBONATE STANDARDS?

The FDA product code for BIOTROL BICARBONATE STANDARDS is JIS.

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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 CNPG3K921677BIOTROL MAGNESIUM (MAGON)K912795BIOTROL UIBC REAGENTK910721BIOTROL PROTEIN MULTILEVEL STANDARDSK905683BIOTROL LACTATE DEHYDROGENASE (L-P)

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Related Devices (Code: JIS)

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.

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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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