Sceptor System Automated Model 216
FDA 510(k) K810229 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK810229
Submission
- Device name
- Sceptor System Automated Model 216
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Walker, MI, US - Received
- January 27, 1981
- Decision date
- February 9, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTC – Device, Microtiter Diluting/Dispensing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2500
- Specialty
- Microbiology
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Questions and answers
When was Sceptor System Automated Model 216 cleared by the FDA?
Sceptor System Automated Model 216 (K810229) received a 510(k) decision of Substantially Equivalent on February 9, 1981, 13 days after the submission was received.
What is the product code of K810229?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.