The following data is part of a premarket notification filed by Consolidated Technologies, Inc. with the FDA for Urine Chemistry Control, Level 1.
| Device ID | K992576 |
| 510k Number | K992576 |
| Device Name: | URINE CHEMISTRY CONTROL, LEVEL 1 |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| 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 | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-02 |
| Decision Date | 1999-09-03 |
| Summary: | summary |