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 | K971221 |
| 510k Number | K971221 |
| Device Name: | GREINER VACUETTE BLOOD COLLECTION TUBE |
| Classification | Tubes, Vacuum Sample, With Anticoagulant |
| 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 | GIM |
| 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 | 1997-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120049203384 | K971221 | 000 |
| 39120017574416 | K971221 | 000 |
| 39120017574485 | K971221 | 000 |
| 39120017574492 | K971221 | 000 |
| 39120017574539 | K971221 | 000 |
| 39120017574607 | K971221 | 000 |
| 39120017574690 | K971221 | 000 |
| 39120017574737 | K971221 | 000 |
| 39120017574782 | K971221 | 000 |
| 39120017574867 | K971221 | 000 |
| 39120017576380 | K971221 | 000 |
| 39120017576960 | K971221 | 000 |
| 39120017576991 | K971221 | 000 |
| 39120017577004 | K971221 | 000 |
| 39120017578926 | K971221 | 000 |
| 39120049200659 | K971221 | 000 |
| 39120017579374 | K971221 | 000 |