The following data is part of a premarket notification filed by In Vitro Diagnostics, Inc. with the FDA for Lithium Internal Standard 1 Meq/l #60085.
| Device ID | K871185 |
| 510k Number | K871185 |
| Device Name: | LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 |
| Classification | Calibrator, Primary |
| Applicant | IN VITRO DIAGNOSTICS, INC. 415 HOWE AVE. Shelton, CT 06484 |
| Contact | Jay Mininberg |
| Correspondent | Jay Mininberg IN VITRO DIAGNOSTICS, INC. 415 HOWE AVE. Shelton, CT 06484 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-24 |
| Decision Date | 1987-05-28 |