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FDA 510(k)

VENTRE/SEP

K-Number: K811423 · 1981-06-09

ApplicantVentrex Laboratories, Inc.
Decision Date1981-06-09
Product CodeCFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VENTRE/SEP 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 1981-06-09 under 510(k) number K811423. The device is classified under product code CFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTRE/SEP?

VENTRE/SEP is a medical device that received FDA 510(k) clearance on 1981-06-09. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K811423.

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

VENTRE/SEP received FDA 510(k) clearance on 1981-06-09, under 510(k) number K811423.

Who is the listed applicant for VENTRE/SEP?

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?

The FDA product code for VENTRE/SEP is CFP.

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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: CFP)

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.

K963911ALPCO/MERCODIA INSULIN ELISAAmerican Laboratory Products Co., Ltd.K953084ACCESS ULTRASENSITIVE INSULIN ASSAYBio-Rad Laboratories, Inc.K920109IMX INSULINAbbott LaboratoriesK914820DSL INSULIN RIA (DSL 1600)Diagnostic Systems Laboratories, Inc.K903628AIA-PACK IRITosoh Corp.K901135ENZYMUN TEST(R) INSULINBoehringer Mannheim 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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