TB Quick Stain(Tm) Kit
FDA 510(k) K871117 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK871117
Submission
- Device name
- TB Quick Stain(Tm) Kit
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- March 19, 1987
- Decision date
- April 3, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ICJ – Carbol Night Blue
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
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Questions and answers
When was TB Quick Stain(Tm) Kit cleared by the FDA?
TB Quick Stain(Tm) Kit (K871117) received a 510(k) decision of Substantially Equivalent on April 3, 1987, 15 days after the submission was received.
What is the product code of K871117?
The FDA product code is ICJ – Carbol Night Blue, a Class I (low risk) device regulated under 21 CFR 864.1850.