The following data is part of a premarket notification filed by Consolidated Technologies, Inc. with the FDA for Qualitrol Igame Controls, Levels 1 And 2.
| Device ID | K961544 |
| 510k Number | K961544 |
| Device Name: | QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 |
| Classification | Whole Human Serum, Antigen, Antiserum, Control |
| Applicant | CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 Austin, TX 78744 -1832 |
| Contact | William Cone |
| Correspondent | William Cone CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 Austin, TX 78744 -1832 |
| Product Code | DGR |
| CFR Regulation Number | 866.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-22 |
| Decision Date | 1996-09-24 |