The following data is part of a premarket notification filed by Seragen Diagnostics, Inc. with the FDA for Quick-chem Calibration Set.
| Device ID | K852260 |
| 510k Number | K852260 |
| Device Name: | QUICK-CHEM CALIBRATION SET |
| Classification | Calibrator, Surrogate |
| Applicant | SERAGEN DIAGNOSTICS, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | Michael J Sullivan |
| Correspondent | Michael J Sullivan SERAGEN DIAGNOSTICS, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | JIW |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-24 |
| Decision Date | 1985-07-22 |