The following data is part of a premarket notification filed by Icn Micromedic Systems with the FDA for Sample Identification Station Model 38010.
| Device ID | K884269 |
| 510k Number | K884269 |
| Device Name: | SAMPLE IDENTIFICATION STATION MODEL 38010 |
| Classification | Counter (beta, Gamma) For Clinical Use |
| Applicant | ICN MICROMEDIC SYSTEMS 102 WITMER RD. Horsham, PA 19044 |
| Contact | Jeffrey Fleishman |
| Correspondent | Jeffrey Fleishman ICN MICROMEDIC SYSTEMS 102 WITMER RD. Horsham, PA 19044 |
| Product Code | JJJ |
| CFR Regulation Number | 862.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-11 |
| Decision Date | 1989-01-09 |