The following data is part of a premarket notification filed by Packard Instrument Co., Inc. with the FDA for Rosys Models 100 And 200.
| Device ID | K913664 |
| 510k Number | K913664 |
| Device Name: | ROSYS MODELS 100 AND 200 |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | PACKARD INSTRUMENT CO., INC. 2200 WARRENVILLE RD. Downers Grove, IL 60515 |
| Contact | Dorothy Mrkvicka |
| Correspondent | Dorothy Mrkvicka PACKARD INSTRUMENT CO., INC. 2200 WARRENVILLE RD. Downers Grove, IL 60515 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-16 |
| Decision Date | 1991-08-30 |