The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Cryptosporidium Ii.
Device ID | K052932 |
510k Number | K052932 |
Device Name: | CRYPTOSPORIDIUM II |
Classification | Cryptosporidium Spp. |
Applicant | TECHLAB, INC. 2001 KRAFT DR. Blacksburg, VA 24060 -6358 |
Contact | David M Lyerly |
Correspondent | David M Lyerly TECHLAB, INC. 2001 KRAFT DR. Blacksburg, VA 24060 -6358 |
Product Code | MHJ |
CFR Regulation Number | 866.3220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-10-19 |
Decision Date | 2005-11-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857031002301 | K052932 | 000 |
00857031002035 | K052932 | 000 |