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 |