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FDA 510(k)

QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION

K-Number: K894039 · 1989-07-14

ApplicantQuidel Corp.
Decision Date1989-07-14
Product CodeDGO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K894039. The device is classified under product code DGO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION?

QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Quidel Corp.. The 510(k) number is K894039.

When did QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION receive FDA 510(k) clearance?

QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION received FDA 510(k) clearance on 1989-07-14, under 510(k) number K894039.

Who is the listed applicant for QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION?

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

What is the FDA product code for QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION?

The FDA product code for QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION is DGO.

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Other records listing Quidel Corp. as applicant

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Related Devices (Code: DGO)

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.

K943194IMMULITE(R) ALLERGY FOOD PANEL FP5EDiagnostic Products Corp.K920087IGE EIA TEST KITThe Binding Site, Ltd.K911511ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIEDDiagnostic Products Corp.K893125BECKMAN EPSILON(TM) IGE REAGENT KITBeckman Instruments, Inc.K872801ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5Diagnostic Products Corp.K860851ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEMNichols Institute Diagnostics

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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