The following data is part of a premarket notification filed by Ind Ndiagnostic Inc. with the FDA for Ind Drug Home Multi-panel Test (2-5) Ind Morphine Home Test.
| Device ID | K121231 |
| 510k Number | K121231 |
| Device Name: | IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST |
| Classification | Saline, Vascular Access Flush |
| Applicant | IND NDIAGNOSTIC INC. 1629 FOSTERS WAY Delta, British Columbia, CA V3m 6s7 |
| Contact | Kai Lou |
| Correspondent | Kai Lou IND NDIAGNOSTIC INC. 1629 FOSTERS WAY Delta, British Columbia, CA V3m 6s7 |
| Product Code | NGT |
| Subsequent Product Code | NFW |
| Subsequent Product Code | NFY |
| Subsequent Product Code | NGG |
| Subsequent Product Code | NGI |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-24 |
| Decision Date | 2012-07-30 |