The following data is part of a premarket notification filed by Consolidated Technologies, Inc. with the FDA for Qualitrol Ana Control Serum Set.
Device ID | K961815 |
510k Number | K961815 |
Device Name: | QUALITROL ANA CONTROL SERUM SET |
Classification | Antinuclear Antibody, Antigen, 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 | LKJ |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-10 |
Decision Date | 1996-09-27 |