FDA 510(k)

VISION PHENYTOIN

K-Number: K896074 · 1989-11-17

Decision Date1989-11-17

Product CodeDIP

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

VISION PHENYTOIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1989-11-17 under 510(k) number K896074. 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 VISION PHENYTOIN?

VISION PHENYTOIN is a medical device that received FDA 510(k) clearance on 1989-11-17. The listed applicant is Abbott Laboratories. The 510(k) number is K896074.

When did VISION PHENYTOIN receive FDA 510(k) clearance?

VISION PHENYTOIN received FDA 510(k) clearance on 1989-11-17, under 510(k) number K896074.

Who is the listed applicant for VISION PHENYTOIN?

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 VISION PHENYTOIN?

The FDA product code for VISION PHENYTOIN is DIP.

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Related Devices (Code: DIP)

K080696ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01Abbott Laboratories K063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLSThermo Electron OY K030428ROCHE 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.