The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Test Plasminogen.
Device ID | K981200 |
510k Number | K981200 |
Device Name: | IL TEST PLASMINOGEN |
Classification | Test, Qualitative And Quantitative Factor Deficiency |
Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
Contact | Carol Marble |
Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
Product Code | GGP |
CFR Regulation Number | 864.7290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-04-02 |
Decision Date | 1998-05-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08426950078975 | K981200 | 000 |