The following data is part of a premarket notification filed by D.r.g. Scientific Industries with the FDA for Osmometer Standard Solutions.
| Device ID | K892329 |
| 510k Number | K892329 |
| Device Name: | OSMOMETER STANDARD SOLUTIONS |
| Classification | Calibrator, Secondary |
| Applicant | D.R.G. SCIENTIFIC INDUSTRIES 1140 SARATOGA ST. East Boston, MA 02128 |
| Contact | Adolph E D'amico |
| Correspondent | Adolph E D'amico D.R.G. SCIENTIFIC INDUSTRIES 1140 SARATOGA ST. East Boston, MA 02128 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-05 |
| Decision Date | 1989-10-31 |