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FDA 510(k)

COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID

K-Number: K953224 · 1995-10-30

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1995-10-30
Product CodeLEG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID 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 1995-10-30 under 510(k) number K953224. 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 APPLICATION FOR FREE VALPROIC ACID?

COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID is a medical device that received FDA 510(k) clearance on 1995-10-30. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K953224.

When did COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID receive FDA 510(k) clearance?

COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID received FDA 510(k) clearance on 1995-10-30, under 510(k) number K953224.

Who is the listed applicant for COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID?

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 APPLICATION FOR FREE VALPROIC ACID?

The FDA product code for COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID 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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