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FDA 510(k)

PH AND AMINES EXTERNAL CONTROL SET

K-Number: K022851 · 2002-09-27

ApplicantQuidel Corp.
Decision Date2002-09-27
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PH AND AMINES EXTERNAL CONTROL SET is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 2002-09-27 under 510(k) number K022851. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PH AND AMINES EXTERNAL CONTROL SET?

PH AND AMINES EXTERNAL CONTROL SET is a medical device that received FDA 510(k) clearance on 2002-09-27. The listed applicant is Quidel Corp.. The 510(k) number is K022851.

When did PH AND AMINES EXTERNAL CONTROL SET receive FDA 510(k) clearance?

PH AND AMINES EXTERNAL CONTROL SET received FDA 510(k) clearance on 2002-09-27, under 510(k) number K022851.

Who is the listed applicant for PH AND AMINES EXTERNAL CONTROL SET?

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 PH AND AMINES EXTERNAL CONTROL SET?

The FDA product code for PH AND AMINES EXTERNAL CONTROL SET is JJY.

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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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