The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Test Free Protein S.
Device ID | K010379 |
510k Number | K010379 |
Device Name: | IL TEST FREE PROTEIN S |
Classification | Test, Qualitative And Quantitative Factor Deficiency |
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 | GGP |
CFR Regulation Number | 864.7290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-02-08 |
Decision Date | 2001-04-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08426950070320 | K010379 | 000 |