The following data is part of a premarket notification filed by Alexon, Inc. with the FDA for Prospect(tm/cryptosporidium.
Device ID | K912242 |
510k Number | K912242 |
Device Name: | PROSPECT(TM/CRYPTOSPORIDIUM |
Classification | Cryptosporidium Spp. |
Applicant | ALEXON, INC. 2319 CHARLESTON RD. Mountain View, CA 94043 |
Contact | Terri A Marello |
Correspondent | Terri A Marello ALEXON, INC. 2319 CHARLESTON RD. Mountain View, CA 94043 |
Product Code | MHJ |
CFR Regulation Number | 866.3220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-21 |
Decision Date | 1992-03-23 |