Haemophilus/Neisseria Identif-Panel
FDA 510(k) K833027 · American Micro Scan
510(k) numberK833027
Submission
- Device name
- Haemophilus/Neisseria Identif-Panel
- Applicant
- American Micro Scan
Mchenry, IL, US - Received
- September 7, 1983
- Decision date
- October 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from American Micro Scan
| 510(k) | Device | Decision |
|---|---|---|
| K870029 | Immunoscan(Tm) Direct Streptococcus PneumoniaeGWC · Traditional | 03/25/1987SE |
| K864662 | Chlamydiae Fluor. AB Test for Detection in SmearsLJP · Traditional | 03/25/1987SE |
| K863776 | Microdilution Mic PanelsJWY · Traditional | 02/02/1987SE |
| K864674 | Microdilution Identification PanelsJSE · Traditional | 01/05/1987SE |
| K864389 | Chlamydiae Flourescent Monoclonal Antibody TestLJP · Traditional | 12/04/1986SE |
| K863038 | Gram Positive Fluorescent Identification PanelLQL · Traditional | 09/30/1986SE |
| K862642 | Gram Negative Fluorescent Identification PanelLQM · Traditional | 09/11/1986SE |
| K862332 | Anaerobe Rapid Chromogenic Id PanelJSP · Traditional | 08/27/1986SE |
| K862140 | Microdilution PanelsJWY · Traditional | 07/16/1986SE |
| K861584 | Gram Negative Combo Panel Type 3JWY · Traditional | 06/17/1986SE |
Questions and answers
When was Haemophilus/Neisseria Identif-Panel cleared by the FDA?
Haemophilus/Neisseria Identif-Panel (K833027) received a 510(k) decision of Substantially Equivalent on October 28, 1983, 51 days after the submission was received.