The following data is part of a premarket notification filed by Gradipore Ltd. with the FDA for Gradileiden V Test.
| Device ID | K992456 |
| 510k Number | K992456 |
| Device Name: | GRADILEIDEN V TEST |
| Classification | Test, Time, Partial Thromboplastin |
| Applicant | GRADIPORE LTD. LOT16 RIVERSIDE CORPORATE PARK 35-105 DELHI ROAD North Ryde, AU Nsw 2113 |
| Contact | Rhonda Pilgrim |
| Correspondent | Rhonda Pilgrim GRADIPORE LTD. LOT16 RIVERSIDE CORPORATE PARK 35-105 DELHI ROAD North Ryde, AU Nsw 2113 |
| Product Code | GGW |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-23 |
| Decision Date | 1999-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768033520 | K992456 | 000 |
| 00630414639758 | K992456 | 000 |