The following data is part of a premarket notification filed by Labsystems, Inc. with the FDA for Auto-eia.
| Device ID | K873583 |
| 510k Number | K873583 |
| Device Name: | AUTO-EIA |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | LABSYSTEMS, INC. 6200 W. OAKTON Morton Grove, IL 60053 |
| Contact | Nancy Skowronski |
| Correspondent | Nancy Skowronski LABSYSTEMS, INC. 6200 W. OAKTON Morton Grove, IL 60053 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-03 |
| Decision Date | 1987-09-22 |