The following data is part of a premarket notification filed by Consolidated Technologies, Inc. with the FDA for Qualitrol, (alfa Fetoprotein) Afp Control Set.
| Device ID | K961912 |
| 510k Number | K961912 |
| Device Name: | QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-17 |
| Decision Date | 1996-08-15 |