The following data is part of a premarket notification filed by Becton Dickinson Advanced Diagnostics with the FDA for Iq Tuptake Assay.
Device ID | K931294 |
510k Number | K931294 |
Device Name: | IQ TUPTAKE ASSAY |
Classification | Radioassay, Triiodothyronine Uptake |
Applicant | BECTON DICKINSON ADVANCED DIAGNOSTICS 10 LOVETON CIRCLE Sparks, MD 21152 |
Contact | Judith J Smith |
Correspondent | Judith J Smith BECTON DICKINSON ADVANCED DIAGNOSTICS 10 LOVETON CIRCLE Sparks, MD 21152 |
Product Code | KHQ |
CFR Regulation Number | 862.1715 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-15 |
Decision Date | 1993-07-22 |