The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Acl Acustar, Hemosil Acustar D-dimer, Hemosil Acustar D-dimer Controls.
| Device ID | K083518 |
| 510k Number | K083518 |
| Device Name: | ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| 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 | JPA |
| Subsequent Product Code | DAP |
| Subsequent Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-26 |
| Decision Date | 2009-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950498032 | K083518 | 000 |
| 08426950496946 | K083518 | 000 |
| 08426950639725 | K083518 | 000 |