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FDA 510(k)

POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK

K-Number: K910082 · 1991-03-12

ApplicantQuidel Corp.
Decision Date1991-03-12
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1991-03-12 under 510(k) number K910082. 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 POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK?

POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK is a medical device that received FDA 510(k) clearance on 1991-03-12. The listed applicant is Quidel Corp.. The 510(k) number is K910082.

When did POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK receive FDA 510(k) clearance?

POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK received FDA 510(k) clearance on 1991-03-12, under 510(k) number K910082.

Who is the listed applicant for POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK?

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 POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK?

The FDA product code for POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK is DGC.

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Other records listing Quidel Corp. as applicant

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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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