The following data is part of a premarket notification filed by Greiner America, Inc. with the FDA for Greiner Vacuette Blood Collection Tube.
| Device ID | K971239 |
| 510k Number | K971239 |
| Device Name: | GREINER VACUETTE BLOOD COLLECTION TUBE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | GREINER AMERICA, INC. P.O. BOX 953279 Lake Mary, FL 32795 -3279 |
| Contact | Ed Maier |
| Correspondent | Ed Maier GREINER AMERICA, INC. P.O. BOX 953279 Lake Mary, FL 32795 -3279 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-02 |
| Decision Date | 1997-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120017579961 | K971239 | 000 |
| 39120017570708 | K971239 | 000 |
| 39120017570838 | K971239 | 000 |
| 39120017570845 | K971239 | 000 |
| 39120017575048 | K971239 | 000 |
| 39120017575130 | K971239 | 000 |
| 39120017575154 | K971239 | 000 |
| 39120017575161 | K971239 | 000 |
| 39120017575178 | K971239 | 000 |
| 39120049208143 | K971239 | 000 |