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FDA 510(k)

COBAS FP REAGENTS FOR PHENYTOIN & CALIBR

K-Number: K843824 · 1985-02-01

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1985-02-01
Product CodeLGR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS FP REAGENTS FOR PHENYTOIN & CALIBR is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1985-02-01 under 510(k) number K843824. The device is classified under product code LGR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS FP REAGENTS FOR PHENYTOIN & CALIBR?

COBAS FP REAGENTS FOR PHENYTOIN & CALIBR is a medical device that received FDA 510(k) clearance on 1985-02-01. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K843824.

When did COBAS FP REAGENTS FOR PHENYTOIN & CALIBR receive FDA 510(k) clearance?

COBAS FP REAGENTS FOR PHENYTOIN & CALIBR received FDA 510(k) clearance on 1985-02-01, under 510(k) number K843824.

Who is the listed applicant for COBAS FP REAGENTS FOR PHENYTOIN & CALIBR?

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

What is the FDA product code for COBAS FP REAGENTS FOR PHENYTOIN & CALIBR?

The FDA product code for COBAS FP REAGENTS FOR PHENYTOIN & CALIBR is LGR.

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Related Devices (Code: LGR)

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.

K955873ACS PHENYTOIN ASSAYCiba Corning Diagnostics Corp.K955562INNOFLUOR PHENYTOIN ASSAY SYSTEMOxis Intl., Inc.K953840AXSYM PHENYTOIN IIAbbott LaboratoriesK946328TDX(R)/TDXFLX(R) PHENYTOIN IIAbbott LaboratoriesK943313PHENYTOIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K935375AXSYM PHENYTOIN ASSAYAbbott Laboratories

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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