The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Microtainer Map Microtube For Automated Process, Model 363706.
Device ID | K093972 |
510k Number | K093972 |
Device Name: | BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | BECTON DICKINSON & CO. 1 BECTON DRIVE, MC 300 Franklin Lakes, NJ 07417 -1880 |
Contact | Julie T Wing |
Correspondent | Julie T Wing BECTON DICKINSON & CO. 1 BECTON DRIVE, MC 300 Franklin Lakes, NJ 07417 -1880 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-24 |
Decision Date | 2010-01-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382903637060 | K093972 | 000 |
30382903637066 | K093972 | 000 |