The following data is part of a premarket notification filed by Lmd Laboratories with the FDA for Cryptosporidium Antigen Detection.
Device ID | K905598 |
510k Number | K905598 |
Device Name: | CRYPTOSPORIDIUM ANTIGEN DETECTION |
Classification | Cryptosporidium Spp. |
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 | MHJ |
CFR Regulation Number | 866.3220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-13 |
Decision Date | 1991-09-05 |