The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Inhibin A Calibrators & Controls On The Access Immunoassay Systems.
| Device ID | K070144 |
| 510k Number | K070144 |
| Device Name: | INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS |
| Classification | Calibrator, Secondary |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Tyler J Foutch |
| Correspondent | Tyler J Foutch BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-02-01 |
| Summary: | summary |