The following data is part of a premarket notification filed by Amtec Diagnostics International Inc. with the FDA for Media, Potentiating For In Vitro Diagnostic Use.
| Device ID | BK860010 |
| 510k Number | BK860010 |
| Device Name: | Media, Potentiating For In Vitro Diagnostic Use |
| Classification | Media, Potentiating For In Vitro Diagnostic Use |
| Applicant | Amtec Diagnostics International Inc. 1107 Ih-45 South Conroe, TX 77305 |
| Product Code | KSG |
| CFR Regulation Number | 864.9600 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-12 |
| Decision Date | 1986-12-16 |