The following data is part of a premarket notification filed by V-tech, Inc. with the FDA for Target Cocaine Metabolite-r.
| Device ID | K910122 |
| 510k Number | K910122 |
| Device Name: | TARGET COCAINE METABOLITE-R |
| Classification | Radioimmunoassay, Cocaine Metabolite |
| Applicant | V-TECH, INC. 9440 TELSTAR AVE., SUITE 7 El Monte, CA 91731 |
| Contact | Willa K Brunkorst |
| Correspondent | Willa K Brunkorst V-TECH, INC. 9440 TELSTAR AVE., SUITE 7 El Monte, CA 91731 |
| Product Code | KLN |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-11 |
| Decision Date | 1991-03-19 |