The following data is part of a premarket notification filed by Greiner Meditech, Inc. with the FDA for Greiner Minicollect Edta Blood Collection Tube.
| Device ID | K982999 |
| 510k Number | K982999 |
| Device Name: | GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | GREINER MEDITECH, INC. 260 GATEWAY DRIVE, SUITE 17A Bel Air, MD 21014 |
| Contact | Doug Harris |
| Correspondent | Doug Harris GREINER MEDITECH, INC. 260 GATEWAY DRIVE, SUITE 17A Bel Air, MD 21014 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-27 |
| Decision Date | 1998-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120017578582 | K982999 | 000 |
| 39120017578551 | K982999 | 000 |
| 39120017577424 | K982999 | 000 |