The following data is part of a premarket notification filed by Akers Biosciences, Inc. with the FDA for Modification To: Instaread Lithium System.
| Device ID | K050338 |
| 510k Number | K050338 |
| Device Name: | MODIFICATION TO: INSTAREAD LITHIUM SYSTEM |
| Classification | Flame Photometry, Lithium |
| Applicant | Akers Biosciences, Inc. 201 GROVE RD. Thorofare, NJ 08086 |
| Contact | Erika Ammirati |
| Correspondent | Erika Ammirati Akers Biosciences, Inc. 201 GROVE RD. Thorofare, NJ 08086 |
| Product Code | JIH |
| CFR Regulation Number | 862.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-11 |
| Decision Date | 2005-03-04 |