The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Low Abnormal Controlled (assayed); Hemosil Low Abnormal Control 2 (unassayed).
| Device ID | K021022 |
| 510k Number | K021022 |
| Device Name: | HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) |
| Classification | Plasma, Coagulation Control |
| 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 | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-29 |
| Decision Date | 2002-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950078982 | K021022 | 000 |
| 08426950660668 | K021022 | 000 |