The following data is part of a premarket notification filed by Greiner America, Inc. with the FDA for Greiner Vacuette Blood Collection Tube W/lithium Heparin & Gel Separator.
| Device ID | K960857 |
| 510k Number | K960857 |
| Device Name: | GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | GREINER AMERICA, INC. 7 HENRY CT. Wilmington, DE 19808 |
| Contact | Ed Maier |
| Correspondent | Ed Maier GREINER AMERICA, INC. 7 HENRY CT. Wilmington, DE 19808 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-01 |
| Decision Date | 1996-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120049204688 | K960857 | 000 |
| 39120017574188 | K960857 | 000 |
| 39120017574065 | K960857 | 000 |
| 39120017574010 | K960857 | 000 |
| 39120017570975 | K960857 | 000 |
| 39120017570968 | K960857 | 000 |
| 39120017570821 | K960857 | 000 |
| 39120049208204 | K960857 | 000 |
| 39120126130930 | K960857 | 000 |
| 39120017579039 | K960857 | 000 |
| 39120017579046 | K960857 | 000 |
| 39120049204671 | K960857 | 000 |
| 39120049204664 | K960857 | 000 |
| 39120049204589 | K960857 | 000 |
| 39120049204572 | K960857 | 000 |
| 39120049204534 | K960857 | 000 |
| 39120049204527 | K960857 | 000 |
| 39120049204510 | K960857 | 000 |
| 39120017579848 | K960857 | 000 |
| 39120126130978 | K960857 | 000 |