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FDA 510(k)

RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN

K-Number: K840103 · 1984-02-10

ApplicantTechniclone Intl.
Decision Date1984-02-10
Product CodeJHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN is the device name listed in this FDA 510(k) record. The listed applicant is Techniclone Intl.. It received FDA 510(k) clearance on 1984-02-10 under 510(k) number K840103. 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 RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN?

RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN is a medical device that received FDA 510(k) clearance on 1984-02-10. The listed applicant is Techniclone Intl.. The 510(k) number is K840103.

When did RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN receive FDA 510(k) clearance?

RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN received FDA 510(k) clearance on 1984-02-10, under 510(k) number K840103.

Who is the listed applicant for RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN?

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

What is the FDA product code for RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN?

The FDA product code for RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN 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.

K061970ELECSYS IGE II IMMUNOASSAYRoche DiagnosticsK984326ELECYS 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.

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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