The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Access Free T4 Reagents On The Access Immunoassay Analyzer.
| Device ID | K982250 |
| 510k Number | K982250 |
| Device Name: | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | BECKMAN INSTRUMENTS, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Shellie Gust |
| Correspondent | Shellie Gust BECKMAN INSTRUMENTS, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-26 |
| Decision Date | 1998-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590225834 | K982250 | 000 |
| 15099590225810 | K982250 | 000 |