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FDA 510(k)

BIOTROL REFERENCE

K-Number: K873118 · 1987-09-02

ApplicantBiotrol, USA, Inc.
Decision Date1987-09-02
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL REFERENCE 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 1987-09-02 under 510(k) number K873118. 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 REFERENCE?

BIOTROL REFERENCE is a medical device that received FDA 510(k) clearance on 1987-09-02. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K873118.

When did BIOTROL REFERENCE receive FDA 510(k) clearance?

BIOTROL REFERENCE received FDA 510(k) clearance on 1987-09-02, under 510(k) number K873118.

Who is the listed applicant for BIOTROL REFERENCE?

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 REFERENCE?

The FDA product code for BIOTROL REFERENCE is JIX.

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Other records listing Biotrol, USA, Inc. as applicant

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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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