Directigen Neisseria Meningitidis Test
FDA 510(k) K920274 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK920274
Submission
- Device name
- Directigen Neisseria Meningitidis Test
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Cockeysville, MD, US - Received
- January 22, 1992
- Decision date
- March 18, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GTI – Antisera, Fluorescent, All Groups, N. Meningitidis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Specialty
- Microbiology
Other 510(k)s with product code GTI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K841308 | Directigen Menningitis Test KitGTI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/02/1984SE |
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Questions and answers
When was Directigen Neisseria Meningitidis Test cleared by the FDA?
Directigen Neisseria Meningitidis Test (K920274) received a 510(k) decision of Substantially Equivalent on March 18, 1992, 56 days after the submission was received.
What is the product code of K920274?
The FDA product code is GTI – Antisera, Fluorescent, All Groups, N. Meningitidis, a Class II (moderate risk) device regulated under 21 CFR 866.3390.