The following data is part of a premarket notification filed by Ocean Scientific, Inc. with the FDA for Mini-chem Analyzer.
| Device ID | K860987 |
| 510k Number | K860987 |
| Device Name: | MINI-CHEM ANALYZER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | OCEAN SCIENTIFIC, INC. 7390 LINCOLN WAY Garden Grove, CA 92641 |
| Contact | Tom Long |
| Correspondent | Tom Long OCEAN SCIENTIFIC, INC. 7390 LINCOLN WAY Garden Grove, CA 92641 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-17 |
| Decision Date | 1986-05-05 |