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 |