The following data is part of a premarket notification filed by Clinical Controls with the FDA for Liquispx Liquid Saliva Or Unrine Drug Of Abuse Control.
Device ID | K012907 |
510k Number | K012907 |
Device Name: | LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL |
Classification | Drug Mixture Control Materials |
Applicant | CLINICAL CONTROLS 12038 CENTRALIA RD. SUITE C Hawaiian Gardens, CA 90716 |
Contact | James F Godfrey |
Correspondent | James F Godfrey CLINICAL CONTROLS 12038 CENTRALIA RD. SUITE C Hawaiian Gardens, CA 90716 |
Product Code | DIF |
CFR Regulation Number | 862.3280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-29 |
Decision Date | 2001-09-28 |