CRYPTOSPORIDIUM ANTIGEN DETECTION

Cryptosporidium Spp.

LMD LABORATORIES

The following data is part of a premarket notification filed by Lmd Laboratories with the FDA for Cryptosporidium Antigen Detection.

Pre-market Notification Details

Device IDK905598
510k NumberK905598
Device Name:CRYPTOSPORIDIUM ANTIGEN DETECTION
ClassificationCryptosporidium Spp.
Applicant LMD LABORATORIES 4626 SANTA FE ST. San Diego,  CA  92109
ContactDave Lambillotte
CorrespondentDave Lambillotte
LMD LABORATORIES 4626 SANTA FE ST. San Diego,  CA  92109
Product CodeMHJ  
CFR Regulation Number866.3220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-13
Decision Date1991-09-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.