Cliniqa Dry QC Chemistry Control, Levels 1 and 2, Assayed, Cliniqa Dry QC Chemistry Control, Level 1 and 2 Unassayed
FDA 510(k) K060322 · Cliniqa Corporation
510(k) numberK060322
Submission
- Device name
- Cliniqa Dry QC Chemistry Control, Levels 1 and 2, Assayed, Cliniqa Dry QC Chemistry Control, Level 1 and 2 Unassayed
- Applicant
- Cliniqa Corporation
Fallbrook, CA, US - Received
- February 9, 2006
- Decision date
- March 21, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Cliniqa Dry QC Chemistry Control, Levels 1 and 2, Assayed, Cliniqa Dry QC Chemistry Control, Level 1 and 2 Unassayed cleared by the FDA?
Cliniqa Dry QC Chemistry Control, Levels 1 and 2, Assayed, Cliniqa Dry QC Chemistry Control, Level 1 and 2 Unassayed (K060322) received a 510(k) decision of Substantially Equivalent on March 21, 2006, 40 days after the submission was received.
What is the product code of K060322?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.