Affinity(Tm) System
FDA 510(k) K865105 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK865105
Submission
- Device name
- Affinity(Tm) System
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- December 30, 1986
- Decision date
- March 12, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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Questions and answers
When was Affinity(Tm) System cleared by the FDA?
Affinity(Tm) System (K865105) received a 510(k) decision of Substantially Equivalent on March 12, 1987, 72 days after the submission was received.
What is the product code of K865105?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.