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FDA 510(k)

QUIDEL CH50 EQ EIA

K-Number: K974111 · 1998-07-29

ApplicantQuidel Corp.
Decision Date1998-07-29
Product CodeDAE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUIDEL CH50 EQ EIA is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1998-07-29 under 510(k) number K974111. The device is classified under product code DAE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIDEL CH50 EQ EIA?

QUIDEL CH50 EQ EIA is a medical device that received FDA 510(k) clearance on 1998-07-29. The listed applicant is Quidel Corp.. The 510(k) number is K974111.

When did QUIDEL CH50 EQ EIA receive FDA 510(k) clearance?

QUIDEL CH50 EQ EIA received FDA 510(k) clearance on 1998-07-29, under 510(k) number K974111.

Who is the listed applicant for QUIDEL CH50 EQ EIA?

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 CH50 EQ EIA?

The FDA product code for QUIDEL CH50 EQ EIA is DAE.

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Other records listing Quidel Corp. 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.

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Related Devices (Code: DAE)

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.

K113349HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FOThe Binding Site Group , Ltd.K992488TOTAL HAEMOLYTIC COMPLEMENT RID KITThe Binding Site, Ltd.K954145WAKO AUTOKIT CH50Wako Chemicals USA, Inc.K951639COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)Incstar 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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