The following data is part of a premarket notification filed by Itl Corporation, Pty Ltd. with the FDA for Samplok Luer Kit.
| Device ID | K021941 |
| 510k Number | K021941 |
| Device Name: | SAMPLOK LUER KIT |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | ITL CORPORATION, PTY LTD. 41-45 TENNANT ST. Fyshwick, Canberra Act, AU 2609 |
| Contact | Wiliam L Mobbs |
| Correspondent | Wiliam L Mobbs ITL CORPORATION, PTY LTD. 41-45 TENNANT ST. Fyshwick, Canberra Act, AU 2609 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-13 |
| Decision Date | 2002-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19555240400052 | K021941 | 000 |
| 19555240400007 | K021941 | 000 |
| 19555240400113 | K021941 | 000 |
| 19555240400199 | K021941 | 000 |