The following data is part of a premarket notification filed by Consolidated Technologies, Inc. with the FDA for Clinical Chemistry Quality Control Material.
| Device ID | K905457 |
| 510k Number | K905457 |
| Device Name: | CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL |
| Classification | Drug Mixture Control Materials |
| Applicant | CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 Austin, TX 78744 -1832 |
| Contact | Charles W Rushing |
| Correspondent | Charles W Rushing CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 Austin, TX 78744 -1832 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-05 |
| Decision Date | 1991-04-16 |