Linical Protein 1 Calibration Verifiers Levels a - E for Olympus Au Analyzers
FDA 510(k) K040927 · Cliniqa Corporation
510(k) numberK040927
Submission
- Device name
- Linical Protein 1 Calibration Verifiers Levels a - E for Olympus Au Analyzers
- Applicant
- Cliniqa Corporation
Fallbrook, CA, US - Received
- April 9, 2004
- Decision date
- May 17, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Linical Protein 1 Calibration Verifiers Levels a - E for Olympus Au Analyzers cleared by the FDA?
Linical Protein 1 Calibration Verifiers Levels a - E for Olympus Au Analyzers (K040927) received a 510(k) decision of Substantially Equivalent on May 17, 2004, 38 days after the submission was received.
What is the product code of K040927?
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.