Biotrol Bilirubin C & T Control
FDA 510(k) K905280 · Biotrol, USA, Inc.
510(k) numberK905280
Submission
- Device name
- Biotrol Bilirubin C & T Control
- Applicant
- Biotrol, USA, Inc.
Westchester, PA, US - Received
- November 23, 1990
- Decision date
- February 4, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Biotrol Bilirubin C & T Control cleared by the FDA?
Biotrol Bilirubin C & T Control (K905280) received a 510(k) decision of Substantially Equivalent on February 4, 1991, 73 days after the submission was received.
What is the product code of K905280?
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.