The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Entamoeba Test.
| Device ID | K944791 |
| 510k Number | K944791 |
| Device Name: | ENTAMOEBA TEST |
| Classification | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| Applicant | TECHLAB, INC. 1861 PRATT DR. CORPORATE RESEARCH CENTER Blacksburg, VA 24060 -6364 |
| Contact | Patricia Shrader |
| Correspondent | Patricia Shrader TECHLAB, INC. 1861 PRATT DR. CORPORATE RESEARCH CENTER Blacksburg, VA 24060 -6364 |
| Product Code | KHW |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-28 |
| Decision Date | 1995-03-09 |