The following data is part of a premarket notification filed by Genprime, Inc with the FDA for Genprime Drugs Of Abuse Reader System.
| Device ID | K130082 |
| 510k Number | K130082 |
| Device Name: | GENPRIME DRUGS OF ABUSE READER SYSTEM |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | GENPRIME, INC 1983 HAZELWOOD ROAD Toms River, NJ 08753 |
| Contact | Maureen Garner |
| Correspondent | Maureen Garner GENPRIME, INC 1983 HAZELWOOD ROAD Toms River, NJ 08753 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DNK |
| Subsequent Product Code | JQT |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-14 |
| Decision Date | 2013-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867802000290 | K130082 | 000 |