The following data is part of a premarket notification filed by Lmd Laboratories with the FDA for Lmd Cryptosporidium Antigen Detection.
| Device ID | K955345 |
| 510k Number | K955345 |
| Device Name: | LMD CRYPTOSPORIDIUM ANTIGEN DETECTION |
| Classification | Cryptosporidium Spp. |
| Applicant | LMD LABORATORIES 2792 LOKER AVE., WEST, #103 SUITE 103 Carlsbad, CA 92008 |
| Contact | David N Lambillotte |
| Correspondent | David N Lambillotte LMD LABORATORIES 2792 LOKER AVE., WEST, #103 SUITE 103 Carlsbad, CA 92008 |
| Product Code | MHJ |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-21 |
| Decision Date | 1996-06-07 |
| Summary: | summary |