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FDA 510(k)

VENTREX COATED TUBE IGE RADIOIMMUNOASSAY

K-Number: K905612 · 1991-02-21

ApplicantVentrex Laboratories, Inc.
Decision Date1991-02-21
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VENTREX COATED TUBE IGE RADIOIMMUNOASSAY 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 1991-02-21 under 510(k) number K905612. 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 VENTREX COATED TUBE IGE RADIOIMMUNOASSAY?

VENTREX COATED TUBE IGE RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1991-02-21. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K905612.

When did VENTREX COATED TUBE IGE RADIOIMMUNOASSAY receive FDA 510(k) clearance?

VENTREX COATED TUBE IGE RADIOIMMUNOASSAY received FDA 510(k) clearance on 1991-02-21, under 510(k) number K905612.

Who is the listed applicant for VENTREX COATED TUBE IGE RADIOIMMUNOASSAY?

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 VENTREX COATED TUBE IGE RADIOIMMUNOASSAY?

The FDA product code for VENTREX COATED TUBE IGE RADIOIMMUNOASSAY 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 PTHK905636VENTREX COATED TUBE IGE ENZYME IMMUNOASSAYK905247SHBG IRMA KITK904330TURBO-RAST SPECIFIC IGE ASSAY

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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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