Sceptorpette System
FDA 510(k) K883907 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK883907
Submission
- Device name
- Sceptorpette System
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- September 15, 1988
- Decision date
- October 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LRG – Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
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| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
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Questions and answers
When was Sceptorpette System cleared by the FDA?
Sceptorpette System (K883907) received a 510(k) decision of Substantially Equivalent on October 27, 1988, 42 days after the submission was received.
What is the product code of K883907?
The FDA product code is LRG – Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.