The following data is part of a premarket notification filed by American Dade with the FDA for Aclaim-qap Ibm Personal Computer Edt.
| Device ID | K833353 |
| 510k Number | K833353 |
| Device Name: | ACLAIM-QAP IBM PERSONAL COMPUTER EDT |
| Classification | Calculator/data Processing Module, For Clinical Use |
| Applicant | AMERICAN DADE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JQP |
| CFR Regulation Number | 862.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-28 |
| Decision Date | 1983-12-22 |