GIARDIA/CRYPTOSPORIDIUM CHEK
Cryptosporidium Spp.
TECHLAB, INC.
The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Giardia/cryptosporidium Chek.
Pre-market Notification Details
| Device ID | K051929 |
| 510k Number | K051929 |
| Device Name: | GIARDIA/CRYPTOSPORIDIUM CHEK |
| Classification | Cryptosporidium Spp. |
| Applicant | TECHLAB, INC. 2001 KRAFT DR. Blacksburg, VA 24060 -6358 |
| Contact | David M Lyrly |
| Correspondent | David M Lyrly TECHLAB, INC. 2001 KRAFT DR. Blacksburg, VA 24060 -6358 |
| Product Code | MHJ |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-13 |
| Decision Date | 2005-11-17 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857031002240 | K051929 | 000 |
| 00857031002127 | K051929 | 000 |
Trademark Results [GIARDIA/CRYPTOSPORIDIUM CHEK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GIARDIA/CRYPTOSPORIDIUM CHEK 78674453 3084001 Live/Registered |
TechLab, Inc. 2005-07-20 |
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