The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Access Afp Reagents On The Access Immunoassay Analyzer Model Number 33211.
| Device ID | K981354 |
| 510k Number | K981354 |
| Device Name: | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 |
| Classification | Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Applicant | BECKMAN INSTRUMENTS, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Ellen M Voss |
| Correspondent | Ellen M Voss BECKMAN INSTRUMENTS, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | LOJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-14 |
| Decision Date | 1998-05-01 |
| Summary: | summary |