The following data is part of a premarket notification filed by American Dade with the FDA for Coagulation Factor Viii Deficient Substrate Plasma.
| Device ID | K853462 |
| 510k Number | K853462 |
| Device Name: | COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | James E Keller |
| Correspondent | James E Keller AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-19 |
| Decision Date | 1985-08-29 |