The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Synthasil.
Device ID | K060688 |
510k Number | K060688 |
Device Name: | HEMOSIL SYNTHASIL |
Classification | Activated Partial Thromboplastin |
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 | GFO |
CFR Regulation Number | 864.7925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-15 |
Decision Date | 2006-04-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08426950087632 | K060688 | 000 |
08426950078920 | K060688 | 000 |