The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Aca Plus Ft4 Calibrator.
| Device ID | K962594 |
| 510k Number | K962594 |
| Device Name: | ACA PLUS FT4 CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | DADE INTL., INC. ROUTE 896 Glasgow, DE 19702 |
| Contact | Cathy P Craft |
| Correspondent | Cathy P Craft DADE INTL., INC. ROUTE 896 Glasgow, DE 19702 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-02 |
| Decision Date | 1996-08-15 |
| Summary: | summary |