The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Modification To Quantimetrix Urine Drugs Of Abuse Control.
| Device ID | K060417 |
| 510k Number | K060417 |
| Device Name: | MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Contact | Jack Coggan |
| Correspondent | Jack Coggan QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-17 |
| Decision Date | 2006-03-21 |
| Summary: | summary |