The following data is part of a premarket notification filed by Gradipore Ltd. with the FDA for Lucor Confirmatory Reagent.
| Device ID | K922156 |
| 510k Number | K922156 |
| Device Name: | LUCOR CONFIRMATORY REAGENT |
| Classification | Reagent, Russel Viper Venom |
| Applicant | GRADIPORE LTD. 200 HARRIS ST. P.O. BOX 65 Pyrmont, AU Nsw 2009 |
| Contact | Manusu |
| Correspondent | Manusu 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 | 1992-05-07 |
| Decision Date | 1993-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768007491 | K922156 | 000 |