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FDA 510(k)

VENTREZYME ALLERGEN DATA REDUCTION SYSTEM

K-Number: K851403 · 1985-06-21

ApplicantVentrex Laboratories, Inc.
Decision Date1985-06-21
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VENTREZYME ALLERGEN DATA REDUCTION SYSTEM 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 1985-06-21 under 510(k) number K851403. The device is classified under product code JQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTREZYME ALLERGEN DATA REDUCTION SYSTEM?

VENTREZYME ALLERGEN DATA REDUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 1985-06-21. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K851403.

When did VENTREZYME ALLERGEN DATA REDUCTION SYSTEM receive FDA 510(k) clearance?

VENTREZYME ALLERGEN DATA REDUCTION SYSTEM received FDA 510(k) clearance on 1985-06-21, under 510(k) number K851403.

Who is the listed applicant for VENTREZYME ALLERGEN DATA REDUCTION SYSTEM?

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 ALLERGEN DATA REDUCTION SYSTEM?

The FDA product code for VENTREZYME ALLERGEN DATA REDUCTION SYSTEM is JQW.

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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: JQW)

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.

K023955BD VIPER INSTRUMENTBecton, Dickinson & COK973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.K9801802700 SAMPLE MANAGERWaters CorporationK970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.K970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics

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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