The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Mastercap Am 5.0/mastercap Rm 5.0.
| Device ID | K970420 |
| 510k Number | K970420 |
| Device Name: | MASTERCAP AM 5.0/MASTERCAP RM 5.0 |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | PHARMACIA, INC. 5094 ST. ANDREWS DR. Westervile, OH 43082 |
| Contact | Karen E Matis |
| Correspondent | Karen E Matis PHARMACIA, INC. 5094 ST. ANDREWS DR. Westervile, OH 43082 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-06-30 |
| Summary: | summary |