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FDA 510(k)

COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS

K-Number: K925003 · 1992-12-03

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1992-12-03
Product CodeLEG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS 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 1992-12-03 under 510(k) number K925003. The device is classified under product code LEG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS?

COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS is a medical device that received FDA 510(k) clearance on 1992-12-03. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K925003.

When did COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS receive FDA 510(k) clearance?

COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS received FDA 510(k) clearance on 1992-12-03, under 510(k) number K925003.

Who is the listed applicant for COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS?

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 REAGENT FOR VALPROIC ACID AND CALIBRATORS?

The FDA product code for COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS is LEG.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: LEG)

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.

K090358ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35Abbott Laboratories, Inc.K060690ONLINE VALPROIC ACIDRoche Diagnostics Corp.K042807ADVIA IMS VALPROIC ACID METHODBayer Healthcare, LLCK042476VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOSOrtho-Clinical Diagnostics, Inc.K032049ROCHE ONLINE TDM VALPROIC ACIDRoche Diagnostics Corp.K031870SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENTBeckman Coulter, 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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