The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Access(r) Psa Reagents On The Access(r) Immunoassay Analyzer 33220, 33225, 33229.
| Device ID | K974816 |
| 510k Number | K974816 |
| Device Name: | ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | BECKMAN INSTRUMENTS, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Ellen Voss |
| Correspondent | Ellen Voss BECKMAN INSTRUMENTS, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-23 |
| Decision Date | 1998-02-20 |
| Summary: | summary |