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FDA 510(k)

BIOTROL CALIBRANT LEVEL 2

K-Number: K875304 · 1988-02-03

ApplicantBiotrol, USA, Inc.
Decision Date1988-02-03
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL CALIBRANT LEVEL 2 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 1988-02-03 under 510(k) number K875304. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTROL CALIBRANT LEVEL 2?

BIOTROL CALIBRANT LEVEL 2 is a medical device that received FDA 510(k) clearance on 1988-02-03. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K875304.

When did BIOTROL CALIBRANT LEVEL 2 receive FDA 510(k) clearance?

BIOTROL CALIBRANT LEVEL 2 received FDA 510(k) clearance on 1988-02-03, under 510(k) number K875304.

Who is the listed applicant for BIOTROL CALIBRANT LEVEL 2?

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 CALIBRANT LEVEL 2?

The FDA product code for BIOTROL CALIBRANT LEVEL 2 is JIX.

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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: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, 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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