The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Liquid Heparin, Heparin Calibrators And Lmw And Uf Heparin Controls.
| Device ID | K090209 |
| 510k Number | K090209 |
| Device Name: | HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS |
| Classification | Assay, Heparin |
| 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 | KFF |
| Subsequent Product Code | GGN |
| Subsequent Product Code | JIS |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-28 |
| Decision Date | 2009-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950478683 | K090209 | 000 |
| 08426950472483 | K090209 | 000 |
| 08426950472476 | K090209 | 000 |
| 08426950580324 | K090209 | 000 |