The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for E. Histolytica Quik Chek.
| Device ID | K170728 |
| 510k Number | K170728 |
| Device Name: | E. HISTOLYTICA QUIK CHEK |
| Classification | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| Applicant | TECHLAB, Inc. 2001 Kraft Drive Blacksburg, VA 24060 -6358 |
| Contact | Donna T. Link |
| Correspondent | Donna T. Link TECHLAB, Inc. 2001 Kraft Drive Blacksburg, VA 24060 -6358 |
| Product Code | KHW |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-09 |
| Decision Date | 2017-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857031002202 | K170728 | 000 |