The following data is part of a premarket notification filed by Akers Laboratories, Inc. with the FDA for Akers Laboratories Inc. Blood Cell Separator.
| Device ID | K030815 |
| 510k Number | K030815 |
| Device Name: | AKERS LABORATORIES INC. BLOOD CELL SEPARATOR |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | AKERS LABORATORIES, INC. 201 GROVE RD. Thorofare, NJ 08086 |
| Contact | Barbara A Bagby |
| Correspondent | Heinz Joerg Steneberg TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-03-14 |
| Decision Date | 2003-09-17 |
| Summary: | summary |