Bactigen-N. Meningitidis
FDA 510(k) K823880 · Armkel, LLC
510(k) numberK823880
Submission
- Device name
- Bactigen-N. Meningitidis
- Applicant
- Armkel, LLC
Walker, MI, US - Received
- December 27, 1982
- Decision date
- March 9, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GTJ – Antisera, All Groups, N. Meningitidis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Specialty
- Microbiology
Other 510(k)s with product code GTJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952791 | Directigen Meningitis Combo TestGTJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/30/1996SE |
| K915330 | Directigen Meningitis Combo Test KitGTJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/23/1992SE |
| K910210 | Slidex Meningite-Kit 5GTJ · Traditional | Vitek Systems, Inc. | 08/12/1991SE |
| K885004 | Bactigen(R) N. MeningitidisGTJ · Traditional | Armkel, LLC | 02/07/1989SE |
| K870089 | Immunoscan(Tm) Direct Neisseria Meningitidis KitGTJ · Traditional | Microscan Div. Baxter Healthcare Corp. | 03/17/1987SE |
| K854852 | Wellcogen Bacterial Antigen KitGTJ · Traditional | Wellcome Diagnostics | 02/04/1986SE |
| K854851 | Wellcogen N. Meningitidis B/E. Coli K1 ZL24GTJ · Traditional | Wellcome Diagnostics | 02/04/1986SE |
| K844999 | Phadebact CSF TestGTJ · Traditional | Pharmacia, Inc. | 10/17/1985SE |
| K851691 | Willcogen Meningitidis Kit ZL25GTJ · Traditional | Wellcome Diagnostics | 06/10/1985SE |
| K844762 | Meningococcus Group B Monoclonal Antibody ZM-51GTJ · Traditional | Wellcome Diagnostics | 06/04/1985SE |
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Questions and answers
When was Bactigen-N. Meningitidis cleared by the FDA?
Bactigen-N. Meningitidis (K823880) received a 510(k) decision of Substantially Equivalent on March 9, 1983, 72 days after the submission was received.
What is the product code of K823880?
The FDA product code is GTJ – Antisera, All Groups, N. Meningitidis, a Class II (moderate risk) device regulated under 21 CFR 866.3390.