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FDA 510(k)

VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT

K-Number: K791355 · 1979-08-10

ApplicantVentrex Laboratories, Inc.
Decision Date1979-08-10
Product CodeDPO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT 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 1979-08-10 under 510(k) number K791355. The device is classified under product code DPO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT?

VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1979-08-10. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K791355.

When did VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1979-08-10, under 510(k) number K791355.

Who is the listed applicant for VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT?

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 DIGOXIN RADIOIMMUNOASSAY KIT?

The FDA product code for VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT is DPO.

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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: DPO)

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.

K914833IMMULITE DIGOXINCirrus Diagnostics, Inc.K905719ECLIPSE ICA DIGOXINBiotope, Inc.K864449DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KITCanadian Bioclinical, Ltd.K833842RIA COAT DIGOXINImmuno Assay Corp.K832163SOPHEIA DIGOXIN EIA KITDiagnostic Products Corp.K830962IMMUCHEM COVALENT-COAT RIA KITImmuchem 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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