The following data is part of a premarket notification filed by Consolidated Technologies, Inc. with the FDA for Qualitrol Unassayed H. Pylori Control Set Positive And Negative Controls.
| Device ID | K972146 |
| 510k Number | K972146 |
| Device Name: | QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS |
| Classification | Helicobacter Pylori |
| Applicant | CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 Austin, TX 78744 -1832 |
| Contact | Vipin D Shah |
| Correspondent | Vipin D Shah CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 Austin, TX 78744 -1832 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-09 |
| Decision Date | 1997-07-08 |