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FDA 510(k)

QUIDEL ALLERGY SCREEN

K-Number: K861171 · 1986-04-25

ApplicantQuidel Corp.
Decision Date1986-04-25
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUIDEL ALLERGY SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1986-04-25 under 510(k) number K861171. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIDEL ALLERGY SCREEN?

QUIDEL ALLERGY SCREEN is a medical device that received FDA 510(k) clearance on 1986-04-25. The listed applicant is Quidel Corp.. The 510(k) number is K861171.

When did QUIDEL ALLERGY SCREEN receive FDA 510(k) clearance?

QUIDEL ALLERGY SCREEN received FDA 510(k) clearance on 1986-04-25, under 510(k) number K861171.

Who is the listed applicant for QUIDEL ALLERGY SCREEN?

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 ALLERGY SCREEN?

The FDA product code for QUIDEL ALLERGY SCREEN is DGC.

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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.

K131813QUIDEL MOLECULAR RSV + HMPV ASSAYK131728QUIDEL MOLECULAR INFLUENZA A + B ASSAYK130398SOFIA(R) RSV FIAK131166SOFIA(R) HCG FIAK131606SOFIA INFLUENZA A+B FIAK131619QUICKVUE INFLUENZA A+B

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Related Devices (Code: DGC)

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.

K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.K214068Quantia IgEBiokit, S.A.K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia ABK063425DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGHDade Behring, 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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