The following data is part of a premarket notification filed by Clinical Controls, Inc. with the FDA for Liquispex(tm) Urine Ethanol Control.
| Device ID | K946144 |
| 510k Number | K946144 |
| Device Name: | LIQUISPEX(TM) URINE ETHANOL CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach, CA 93433 |
| Contact | James F Godfrey |
| Correspondent | James F Godfrey CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach, CA 93433 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-16 |
| Decision Date | 1995-02-08 |