LD Presumpto Quad
FDA 510(k) K871907 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK871907
Submission
- Device name
- LD Presumpto Quad
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- May 15, 1987
- Decision date
- May 28, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTO – Discs, Strips And Reagents, Microorganism Differentiation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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Questions and answers
When was LD Presumpto Quad cleared by the FDA?
LD Presumpto Quad (K871907) received a 510(k) decision of Substantially Equivalent on May 28, 1987, 13 days after the submission was received.
What is the product code of K871907?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.