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FDA 510(k)

VENTREZYME PHENYTOIN KIT IMMUNOASSAY

K-Number: K842161 · 1984-07-09

ApplicantVentrex Laboratories, Inc.
Decision Date1984-07-09
Product CodeDIP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VENTREZYME PHENYTOIN KIT IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Ventrex Laboratories, Inc.. It received FDA 510(k) clearance on 1984-07-09 under 510(k) number K842161. 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 VENTREZYME PHENYTOIN KIT IMMUNOASSAY?

VENTREZYME PHENYTOIN KIT IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1984-07-09. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K842161.

When did VENTREZYME PHENYTOIN KIT IMMUNOASSAY receive FDA 510(k) clearance?

VENTREZYME PHENYTOIN KIT IMMUNOASSAY received FDA 510(k) clearance on 1984-07-09, under 510(k) number K842161.

Who is the listed applicant for VENTREZYME PHENYTOIN KIT IMMUNOASSAY?

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

What is the FDA product code for VENTREZYME PHENYTOIN KIT IMMUNOASSAY?

The FDA product code for VENTREZYME PHENYTOIN KIT IMMUNOASSAY is DIP.

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Other records listing Ventrex 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.

K914554SPECIFIC IGE EIA-TURBO ASSAYK913833VENTREX ALLERGEN DISCK913434VENTREX COATED TUBE INTACT PTHK905612VENTREX COATED TUBE IGE RADIOIMMUNOASSAYK905636VENTREX COATED TUBE IGE ENZYME IMMUNOASSAYK905247SHBG IRMA KIT

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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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