The following data is part of a premarket notification filed by Greiner Bio-one North America, Inc. with the FDA for Blood Culture Holder.
| Device ID | K122687 |
| 510k Number | K122687 |
| Device Name: | BLOOD CULTURE HOLDER |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | GREINER BIO-ONE NORTH AMERICA, INC. P.O. BOX 103 Baldwin, MD 21013 |
| Contact | Judi Smith |
| Correspondent | Judi Smith GREINER BIO-ONE NORTH AMERICA, INC. P.O. BOX 103 Baldwin, MD 21013 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-04 |
| Decision Date | 2013-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120017577448 | K122687 | 000 |
| 29120017577724 | K122687 | 000 |
| 39120017577714 | K122687 | 000 |
| 29120017577700 | K122687 | 000 |
| 29120017577694 | K122687 | 000 |