The following data is part of a premarket notification filed by Gilford Instrument Laboratories, Inc. with the FDA for Ames/gilford Optimate Clin. Chem & Ther.
| Device ID | K821583 |
| 510k Number | K821583 |
| Device Name: | AMES/GILFORD OPTIMATE CLIN. CHEM & THER |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | GILFORD INSTRUMENT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJF |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-28 |
| Decision Date | 1982-06-24 |