The following data is part of a premarket notification filed by Gradipore Ltd. with the FDA for Lupo-test Reagent.
| Device ID | K903037 |
| 510k Number | K903037 |
| Device Name: | LUPO-TEST REAGENT |
| Classification | Reagent, Russel Viper Venom |
| Applicant | GRADIPORE LTD. 200 HARRIS ST. P.O. BOX 65 Pyrmont, AU Nsw 2009 |
| Contact | Rhonda Smyth |
| Correspondent | Rhonda Smyth GRADIPORE LTD. 200 HARRIS ST. P.O. BOX 65 Pyrmont, AU Nsw 2009 |
| Product Code | GIR |
| CFR Regulation Number | 864.8950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-11 |
| Decision Date | 1990-12-17 |