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FDA 510(k)

ELECSYS IGE II IMMUNOASSAY

K-Number: K061970 · 2006-08-31

ApplicantRoche Diagnostics
Decision Date2006-08-31
Product CodeJHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELECSYS IGE II IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2006-08-31 under 510(k) number K061970. 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 ELECSYS IGE II IMMUNOASSAY?

ELECSYS IGE II IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2006-08-31. The listed applicant is Roche Diagnostics. The 510(k) number is K061970.

When did ELECSYS IGE II IMMUNOASSAY receive FDA 510(k) clearance?

ELECSYS IGE II IMMUNOASSAY received FDA 510(k) clearance on 2006-08-31, under 510(k) number K061970.

Who is the listed applicant for ELECSYS IGE II IMMUNOASSAY?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECSYS IGE II IMMUNOASSAY?

The FDA product code for ELECSYS IGE II IMMUNOASSAY is JHR.

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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.

K984326ELECYS IGE ASSAYBoehringer Mannheim Corp.K960067IMMILITE TOTAL IGEDiagnostic Products Corp.K931703IMMULITE TOTAL IGEDiagnostic Products Corp.K903000TURBO-RAST SPECIFIC IGE ASSAYVentrex Laboratories, Inc.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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