PH and Amines External Control Set
FDA 510(k) K022851 · Quidel Corp.
510(k) numberK022851
Submission
- Device name
- PH and Amines External Control Set
- Applicant
- Quidel Corp.
San Diego, CA, US - Received
- August 27, 2002
- Decision date
- September 27, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was PH and Amines External Control Set cleared by the FDA?
PH and Amines External Control Set (K022851) received a 510(k) decision of Substantially Equivalent on September 27, 2002, 31 days after the submission was received.
What is the product code of K022851?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.