The following data is part of a premarket notification filed by Greiner Bio-one Na Inc. with the FDA for Minicollect K2e K2edta Tubes.
| Device ID | K182078 |
| 510k Number | K182078 |
| Device Name: | MiniCollect K2E K2EDTA Tubes |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| 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 | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-02 |
| Decision Date | 2019-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 49120049206030 | K182078 | 000 |
| 39120049203568 | K182078 | 000 |