Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG Calibration Verification Controls Le
FDA 510(k) K121237 · Cliniqa Corporation
510(k) numberK121237
Submission
- Device name
- Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG Calibration Verification Controls Le
- Applicant
- Cliniqa Corporation
San Marcos, CA, US - Received
- April 24, 2012
- Decision date
- May 18, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG Calibration Verification Controls Le cleared by the FDA?
Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG Calibration Verification Controls Le (K121237) received a 510(k) decision of Substantially Equivalent on May 18, 2012, 24 days after the submission was received.
What is the product code of K121237?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.