The following data is part of a premarket notification filed by Lmd Laboratories with the FDA for Cysticercosis Serological Reagents.
Device ID | K900780 |
510k Number | K900780 |
Device Name: | CYSTICERCOSIS SEROLOGICAL REAGENTS |
Classification | Reagents, Cysticercosis |
Applicant | LMD LABORATORIES 4626 SANTA FE ST. San Diego, CA 92109 |
Contact | Dave Lambillotte |
Correspondent | Dave Lambillotte LMD LABORATORIES 4626 SANTA FE ST. San Diego, CA 92109 |
Product Code | MDJ |
CFR Regulation Number | 866.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-20 |
Decision Date | 1990-10-04 |