Immunoscan(Tm) Direct Neisseria Meningitidis Kit
FDA 510(k) K870089 · Microscan Div. Baxter Healthcare Corp.
510(k) numberK870089
Submission
- Device name
- Immunoscan(Tm) Direct Neisseria Meningitidis Kit
- Applicant
- Microscan Div. Baxter Healthcare Corp.
West Sacramento, CA, US - Received
- January 9, 1987
- Decision date
- March 17, 1987
- 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 |
| 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 |
| K844407 | Directigen Neissena Menningitidis Group B TestGTJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/25/1985SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K871234 | Antibody Assay for Detect. of Parainfluenza Type 1GQS · Traditional | 06/26/1987SE |
| K871233 | Antibody Assay for Detection of Influenza aGNX · Traditional | 06/26/1987SE |
| K871232 | Antibody Assay for Detect. of Parainfluenza Type 3GQS · Traditional | 06/26/1987SE |
| K871231 | Antibody Assay for Detection of Influenza BGNX · Traditional | 06/26/1987SE |
| K871230 | Antibody Assay for Detec. of Resp. Syncytial VirusLKT · Traditional | 06/26/1987SE |
| K871229 | Antibody Assay for Detection of Adenovirus in CellGOD · Traditional | 06/26/1987SE |
| K871228 | Antibody Assay for Detect. of Parainfluenza Type 2GQS · Traditional | 06/26/1987SE |
| K870814 | Herpes Simplex Antibody Test for Dect. of HSV 1&2GQL · Traditional | 06/04/1987SE |
| K870074 | Gram Negative and Gram Positive Mic/Combo PanelsJWY · Traditional | 04/14/1987SE |
| K871033 | Rabbit Kidney Culture Cells (First Pass)KIR · Traditional | 03/31/1987SE |
Questions and answers
When was Immunoscan(Tm) Direct Neisseria Meningitidis Kit cleared by the FDA?
Immunoscan(Tm) Direct Neisseria Meningitidis Kit (K870089) received a 510(k) decision of Substantially Equivalent on March 17, 1987, 67 days after the submission was received.
What is the product code of K870089?
The FDA product code is GTJ – Antisera, All Groups, N. Meningitidis, a Class II (moderate risk) device regulated under 21 CFR 866.3390.