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FDA 510(k)

VENTRE/SPEC ALLERGEN CONTROL-INHALANT

K-Number: K820978 · 1982-06-11

ApplicantVentrex Laboratories, Inc.
Decision Date1982-06-11
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VENTRE/SPEC ALLERGEN CONTROL-INHALANT 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 1982-06-11 under 510(k) number K820978. 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 VENTRE/SPEC ALLERGEN CONTROL-INHALANT?

VENTRE/SPEC ALLERGEN CONTROL-INHALANT is a medical device that received FDA 510(k) clearance on 1982-06-11. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K820978.

When did VENTRE/SPEC ALLERGEN CONTROL-INHALANT receive FDA 510(k) clearance?

VENTRE/SPEC ALLERGEN CONTROL-INHALANT received FDA 510(k) clearance on 1982-06-11, under 510(k) number K820978.

Who is the listed applicant for VENTRE/SPEC ALLERGEN CONTROL-INHALANT?

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/SPEC ALLERGEN CONTROL-INHALANT?

The FDA product code for VENTRE/SPEC ALLERGEN CONTROL-INHALANT is DGC.

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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: DGC)

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.

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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