The following data is part of a premarket notification filed by Micromedic Systems with the FDA for Mms T3 Uptake.
Device ID | K861262 |
510k Number | K861262 |
Device Name: | MMS T3 UPTAKE |
Classification | Radioassay, Triiodothyronine Uptake |
Applicant | MICROMEDIC SYSTEMS 102 WITMER RD. Horsham, PA 19044 |
Contact | Deborah L Lindemuth |
Correspondent | Deborah L Lindemuth MICROMEDIC SYSTEMS 102 WITMER RD. Horsham, PA 19044 |
Product Code | KHQ |
CFR Regulation Number | 862.1715 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-04 |
Decision Date | 1986-05-23 |