The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Vacutainer Ultratouch Push Button Blood Collection Set.
Device ID | K212724 |
510k Number | K212724 |
Device Name: | BD Vacutainer UltraTouch Push Button Blood Collection Set |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
Contact | Katherine Kenner Lemus |
Correspondent | Katherine Kenner Lemus Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-08-27 |
Decision Date | 2022-02-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382903673921 | K212724 | 000 |
00382903673919 | K212724 | 000 |
00382903673650 | K212724 | 000 |
00382903673643 | K212724 | 000 |
00382903673636 | K212724 | 000 |
30382903673934 | K212724 | 000 |
30382903673927 | K212724 | 000 |
30382903673910 | K212724 | 000 |
30382903673651 | K212724 | 000 |
30382903673644 | K212724 | 000 |
00382903673926 | K212724 | 000 |
30382903686866 | K212724 | 000 |
30382903686842 | K212724 | 000 |
50382903673914 | K212724 | 000 |
50382903673655 | K212724 | 000 |
50382903673648 | K212724 | 000 |
50382903673631 | K212724 | 000 |
00382903673933 | K212724 | 000 |
30382903686897 | K212724 | 000 |
30382903686880 | K212724 | 000 |
30382903686873 | K212724 | 000 |
30382903686859 | K212724 | 000 |
30382903673637 | K212724 | 000 |