The following data is part of a premarket notification filed by Consolidated Technologies, Inc. with the FDA for Qualitrol Urinalysis With Microscopics Control, Levels 1,2 And 3.
Device ID | K000116 |
510k Number | K000116 |
Device Name: | QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 Austin, TX 78744 -1832 |
Contact | Rusty Sewell |
Correspondent | Rusty Sewell 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 | 2000-01-14 |
Decision Date | 2000-02-15 |