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FDA 510(k)

VIRGO IPA FOR DETECTION OF PHENYTOIN

K-Number: K811745 · 1981-07-10

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1981-07-10
Product CodeDIP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VIRGO IPA FOR DETECTION OF PHENYTOIN is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811745. 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 VIRGO IPA FOR DETECTION OF PHENYTOIN?

VIRGO IPA FOR DETECTION OF PHENYTOIN is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K811745.

When did VIRGO IPA FOR DETECTION OF PHENYTOIN receive FDA 510(k) clearance?

VIRGO IPA FOR DETECTION OF PHENYTOIN received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811745.

Who is the listed applicant for VIRGO IPA FOR DETECTION OF PHENYTOIN?

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

What is the FDA product code for VIRGO IPA FOR DETECTION OF PHENYTOIN?

The FDA product code for VIRGO IPA FOR DETECTION OF PHENYTOIN is DIP.

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Other records listing Electro-Nucleonics Laboratories, Inc. as applicant

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.

K873925VIRGO(TM) MEASLES IGG ELISAK873617GEMSTAR II SYSTEMK873416MULTI-ACCESS REAGENT DISPENSERK873358GEMENI URIC ACID U.V.K873088VIRGO(TM) RUBELLA IGG ELISAK871905TOXOPLASMA GONDII IGG ELISA

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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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