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FDA 510(k)

VENTRE/SEP T3 TEST SET

K-Number: K791588 · 1979-09-27

ApplicantVentrex Laboratories, Inc.
Decision Date1979-09-27
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VENTRE/SEP T3 TEST SET 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 1979-09-27 under 510(k) number K791588. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTRE/SEP T3 TEST SET?

VENTRE/SEP T3 TEST SET is a medical device that received FDA 510(k) clearance on 1979-09-27. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K791588.

When did VENTRE/SEP T3 TEST SET receive FDA 510(k) clearance?

VENTRE/SEP T3 TEST SET received FDA 510(k) clearance on 1979-09-27, under 510(k) number K791588.

Who is the listed applicant for VENTRE/SEP T3 TEST SET?

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 VENTRE/SEP T3 TEST SET?

The FDA product code for VENTRE/SEP T3 TEST SET is CDP.

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Other records listing Ventrex Laboratories, Inc. as applicant

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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: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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