The following data is part of a premarket notification filed by Ind Diagnostic Inc. with the FDA for Cassette/urine Hcg.
| Device ID | K023638 |
| 510k Number | K023638 |
| Device Name: | CASSETTE/URINE HCG |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | IND DIAGNOSTIC INC. 1629 FOSTERS WAY Delta, Bc, CA V3m 6s7 |
| Contact | David Lee |
| Correspondent | David Lee IND DIAGNOSTIC INC. 1629 FOSTERS WAY Delta, Bc, CA V3m 6s7 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-30 |
| Decision Date | 2003-01-03 |