The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Access Total Bhcg Reagents On The Access Immunoassay Analyzer; 33500, 33505.
| Device ID | K980173 |
| 510k Number | K980173 |
| Device Name: | ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | BECKMAN INSTRUMENTS, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Sandra F Schwartz |
| Correspondent | Sandra F Schwartz BECKMAN INSTRUMENTS, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-20 |
| Decision Date | 1998-03-18 |
| Summary: | summary |