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FDA 510(k)

A-GENT PHERYTOIN

K-Number: K832419 · 1983-09-01

ApplicantAbbott Laboratories
Decision Date1983-09-01
Product CodeDIP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

A-GENT PHERYTOIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1983-09-01 under 510(k) number K832419. The device is classified under product code DIP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-GENT PHERYTOIN?

A-GENT PHERYTOIN is a medical device that received FDA 510(k) clearance on 1983-09-01. The listed applicant is Abbott Laboratories. The 510(k) number is K832419.

When did A-GENT PHERYTOIN receive FDA 510(k) clearance?

A-GENT PHERYTOIN received FDA 510(k) clearance on 1983-09-01, under 510(k) number K832419.

Who is the listed applicant for A-GENT PHERYTOIN?

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

What is the FDA product code for A-GENT PHERYTOIN?

The FDA product code for A-GENT PHERYTOIN is DIP.

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Other records listing Abbott Laboratories as applicant

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Related Devices (Code: DIP)

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.

K080696ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01Abbott LaboratoriesK063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLSThermo Electron OYK030428ROCHE ONLINE TDM PHENYTOINRoche Diagnostics Corp.K011393RANDOX PHENYTOINRandox Laboratories, Ltd.K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229Syva Co.K000006IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6Diagnostic Products Corp.

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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