The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Acustar Cardiolipin Igg, Igm And Igg And Igm Controls.
| Device ID | K092181 |
| 510k Number | K092181 |
| Device Name: | HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS |
| Classification | System, Test, Anticardiolipin Immunological |
| 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 | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-21 |
| Decision Date | 2010-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426951289295 | K092181 | 000 |
| 08426951289240 | K092181 | 000 |
| 08426950497004 | K092181 | 000 |
| 08426950496991 | K092181 | 000 |
| 08426950496960 | K092181 | 000 |
| 08426950496953 | K092181 | 000 |