The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Clotting Factor-11,-vii, -x Deficient Plasma.
| Device ID | K924400 |
| 510k Number | K924400 |
| Device Name: | CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA |
| Classification | Plasma, Coagulation Factor Deficient |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | Joseph Kiceina |
| Correspondent | Joseph Kiceina BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | GJT |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-31 |
| Decision Date | 1993-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768011030 | K924400 | 000 |
| 00842768010958 | K924400 | 000 |
| 00842768010156 | K924400 | 000 |
| 00842768018848 | K924400 | 000 |
| 00842768018855 | K924400 | 000 |
| 00842768018817 | K924400 | 000 |