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FDA 510(k)

AMES TDA VALPROIC ACID TEST

K-Number: K830789 · 1983-04-12

ApplicantMiles Laboratories, Inc.
Decision Date1983-04-12
Product CodeLEG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMES TDA VALPROIC ACID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830789. 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 AMES TDA VALPROIC ACID TEST?

AMES TDA VALPROIC ACID TEST is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K830789.

When did AMES TDA VALPROIC ACID TEST receive FDA 510(k) clearance?

AMES TDA VALPROIC ACID TEST received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830789.

Who is the listed applicant for AMES TDA VALPROIC ACID TEST?

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

What is the FDA product code for AMES TDA VALPROIC ACID TEST?

The FDA product code for AMES TDA VALPROIC ACID TEST is LEG.

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Other records listing Miles Laboratories, 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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