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FDA 510(k)

TURBO-RAST SPECIFIC IGE ASSAY

K-Number: K903000 · 1990-07-31

ApplicantVentrex Laboratories, Inc.
Decision Date1990-07-31
Product CodeJHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TURBO-RAST SPECIFIC IGE ASSAY 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 1990-07-31 under 510(k) number K903000. The device is classified under product code JHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TURBO-RAST SPECIFIC IGE ASSAY?

TURBO-RAST SPECIFIC IGE ASSAY is a medical device that received FDA 510(k) clearance on 1990-07-31. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K903000.

When did TURBO-RAST SPECIFIC IGE ASSAY receive FDA 510(k) clearance?

TURBO-RAST SPECIFIC IGE ASSAY received FDA 510(k) clearance on 1990-07-31, under 510(k) number K903000.

Who is the listed applicant for TURBO-RAST SPECIFIC IGE ASSAY?

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 TURBO-RAST SPECIFIC IGE ASSAY?

The FDA product code for TURBO-RAST SPECIFIC IGE ASSAY is JHR.

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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: JHR)

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.

K061970ELECSYS IGE II IMMUNOASSAYRoche DiagnosticsK984326ELECYS IGE ASSAYBoehringer Mannheim Corp.K960067IMMILITE TOTAL IGEDiagnostic Products Corp.K931703IMMULITE TOTAL IGEDiagnostic Products Corp.K901859COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2Diagnostic Products Corp.K882616ALTERNATE PROCEDURE, PHARMACIA IGE EIAPharmacia, 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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