The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Preciset Dat Amphetamine.
| Device ID | K030826 |
| 510k Number | K030826 |
| Device Name: | PRECISET DAT AMPHETAMINE |
| Classification | Lead, Delta Amino Levulinic Acid |
| Applicant | QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Contact | Gebhard Neyer |
| Correspondent | Gebhard Neyer QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Product Code | DIJ |
| CFR Regulation Number | 862.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-14 |
| Decision Date | 2003-04-03 |
| Summary: | summary |