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 |