The following data is part of a premarket notification filed by Beckman Analytical And Biotechnology Development with the FDA for Biomek Sl With Biomek Sl Incubator.
| Device ID | K941498 |
| 510k Number | K941498 |
| Device Name: | BIOMEK SL WITH BIOMEK SL INCUBATOR |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | BECKMAN ANALYTICAL AND BIOTECHNOLOGY DEVELOPMENT 2500 HARBOR BLVD. Fullerton, CA 92634 |
| Contact | F. David Kalfell |
| Correspondent | F. David Kalfell BECKMAN ANALYTICAL AND BIOTECHNOLOGY DEVELOPMENT 2500 HARBOR BLVD. Fullerton, CA 92634 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-28 |
| Decision Date | 1994-07-14 |