The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Thyrus.
Device ID | K930283 |
510k Number | K930283 |
Device Name: | THYRUS |
Classification | Camera, Scintillation (gamma) |
Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Contact | Paul Vicha |
Correspondent | Paul Vicha ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Product Code | IYX |
CFR Regulation Number | 892.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-21 |
Decision Date | 1993-06-21 |