The following data is part of a premarket notification filed by Greiner America, Inc. with the FDA for Greiner Vacuette Blood Collection Tube E/edta K3.
Device ID | K960860 |
510k Number | K960860 |
Device Name: | GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3 |
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 | 1996-09-05 |
Summary: | summary |