The following data is part of a premarket notification filed by Graoipore Ltd. with the FDA for Lupo-test Regeant.
| Device ID | K922326 |
| 510k Number | K922326 |
| Device Name: | LUPO-TEST REGEANT |
| Classification | Reagent, Russel Viper Venom |
| Applicant | GRAOIPORE LTD. 200 HARRIS ST. SYDNEY NSW 2009, P.O. BOX 65 Pyrmont 2009 Australia, AU |
| Contact | Manusu |
| Correspondent | Manusu GRAOIPORE LTD. 200 HARRIS ST. SYDNEY NSW 2009, P.O. BOX 65 Pyrmont 2009 Australia, AU |
| Product Code | GIR |
| CFR Regulation Number | 864.8950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-11 |
| Decision Date | 1993-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768007477 | K922326 | 000 |