The following data is part of a premarket notification filed by Itl Corporation, Pty Ltd. with the FDA for Samplok.
Device ID | K000777 |
510k Number | K000777 |
Device Name: | SAMPLOK |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | ITL CORPORATION, PTY LTD. 15825 SHADY GROVE RD. SUITE 90 Rockville, MD 20850 |
Contact | Kenneth A Palmer |
Correspondent | Kenneth A Palmer ITL CORPORATION, PTY LTD. 15825 SHADY GROVE RD. SUITE 90 Rockville, MD 20850 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-09 |
Decision Date | 2000-04-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
19555240401226 | K000777 | 000 |
19555240401523 | K000777 | 000 |
19555240401530 | K000777 | 000 |
19555240401547 | K000777 | 000 |
19555240401554 | K000777 | 000 |
19555240400021 | K000777 | 000 |
19555240400069 | K000777 | 000 |
19555240400175 | K000777 | 000 |
19555240400205 | K000777 | 000 |
19555240401301 | K000777 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SAMPLOK 98099921 not registered Live/Pending |
Noble House Group Pty. Ltd. 2023-07-25 |
SAMPLOK 75881897 2756567 Live/Registered |
Noble House Group Pty Ltd. 1999-12-27 |