Bactigen(R) Meningitidis Panel
FDA 510(k) K884965 · Armkel, LLC
510(k) numberK884965
Submission
- Device name
- Bactigen(R) Meningitidis Panel
- Applicant
- Armkel, LLC
Cranbury, NJ, US - Received
- November 30, 1988
- Decision date
- February 7, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GWC – Antisera, All Types, Streptococcus Pneumoniae
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
Other 510(k)s with product code GWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884966 | Bactigen(R) S. PneumoniaeGWC · Traditional | Armkel, LLC | 02/07/1989SE |
| K870029 | Immunoscan(Tm) Direct Streptococcus PneumoniaeGWC · Traditional | American Micro Scan | 03/25/1987SE |
| K862848 | LKB Ultrobact (TM) Pneumococcus Kit; 2321-110GWC · Traditional | Lkb Instruments, Inc. | 12/18/1986SE |
| K842239 | Ventrescreen Strep a TestGWC · Traditional | Ventrex Laboratories, Inc. | 07/02/1984SE |
| K841376 | Wellcogen S. PneumoniaeGWC · Traditional | Wellcome Diagnostics | 05/02/1984SE |
| K831887 | Bactigen S. PneumoniaeGWC · Traditional | Armkel, LLC | 09/26/1983SE |
| K821960 | BBL Pneumoslide TestGWC · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/30/1982SE |
| K802337 | Phadebact Pneumococcus TestGWC · Traditional | Pharmacia, Inc. | 10/31/1980SE |
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Questions and answers
When was Bactigen(R) Meningitidis Panel cleared by the FDA?
Bactigen(R) Meningitidis Panel (K884965) received a 510(k) decision of Substantially Equivalent on February 7, 1989, 69 days after the submission was received.
What is the product code of K884965?
The FDA product code is GWC – Antisera, All Types, Streptococcus Pneumoniae, a Class I (low risk) device regulated under 21 CFR 866.3740.