The following data is part of a premarket notification filed by Greiner Bio-one Na Inc. with the FDA for Greiner Vacuette Urine Count And Culture, Mannitol Tube.
| Device ID | K163436 |
| 510k Number | K163436 |
| Device Name: | Greiner Vacuette Urine Count And Culture, Mannitol Tube |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | GREINER BIO-ONE NA INC. 4238 CAPITAL DRIVE Monroe, NC 28110 |
| Contact | Manfred Abel |
| Correspondent | Manfred Abel GREINER BIO-ONE NA INC. 4238 CAPITAL DRIVE Monroe, NC 28110 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-07 |
| Decision Date | 2017-03-06 |
| Summary: | summary |