The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Factor Xii Deficient Plasma.
| Device ID | K043459 |
| 510k Number | K043459 |
| Device Name: | HEMOSIL FACTOR XII DEFICIENT PLASMA |
| Classification | Plasma, Coagulation Factor Deficient |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | GJT |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-15 |
| Decision Date | 2005-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950479277 | K043459 | 000 |