The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Factor Ii Deficient Plasma.
Device ID | K050661 |
510k Number | K050661 |
Device Name: | HEMOSIL FACTOR II 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 | 2005-03-15 |
Decision Date | 2005-05-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08426950484738 | K050661 | 000 |