The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for E. Histolytica Ii.
| Device ID | K994101 |
| 510k Number | K994101 |
| Device Name: | E. HISTOLYTICA II |
| Classification | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| Applicant | TECHLAB, INC. 1861 PRATT DR., STE. 1030 Blacksburg, VA 24060 -6364 |
| Contact | David M Lyerly |
| Correspondent | David M Lyerly TECHLAB, INC. 1861 PRATT DR., STE. 1030 Blacksburg, VA 24060 -6364 |
| Product Code | KHW |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-06 |
| Decision Date | 1999-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857031002349 | K994101 | 000 |
| 00857031002011 | K994101 | 000 |