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FDA 510(k)

NEW ALLERGEN DISCS FOR USE IN VAST VENT

K-Number: K830817 · 1983-04-27

ApplicantVentrex Laboratories, Inc.
Decision Date1983-04-27
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NEW ALLERGEN DISCS FOR USE IN VAST VENT 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 1983-04-27 under 510(k) number K830817. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEW ALLERGEN DISCS FOR USE IN VAST VENT?

NEW ALLERGEN DISCS FOR USE IN VAST VENT is a medical device that received FDA 510(k) clearance on 1983-04-27. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K830817.

When did NEW ALLERGEN DISCS FOR USE IN VAST VENT receive FDA 510(k) clearance?

NEW ALLERGEN DISCS FOR USE IN VAST VENT received FDA 510(k) clearance on 1983-04-27, under 510(k) number K830817.

Who is the listed applicant for NEW ALLERGEN DISCS FOR USE IN VAST VENT?

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 NEW ALLERGEN DISCS FOR USE IN VAST VENT?

The FDA product code for NEW ALLERGEN DISCS FOR USE IN VAST VENT is DGC.

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Other records listing Ventrex Laboratories, Inc. as applicant

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Related Devices (Code: DGC)

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K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.K214068Quantia IgEBiokit, S.A.K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia ABK063425DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGHDade Behring, Inc.

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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