The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Tri-combo Parasite Screen.
| Device ID | K171078 |
| 510k Number | K171078 |
| Device Name: | TRI-COMBO PARASITE SCREEN |
| Classification | Cryptosporidium 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 | MHJ |
| Subsequent Product Code | KHW |
| Subsequent Product Code | MHI |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-11 |
| Decision Date | 2017-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857031002400 | K171078 | 000 |
| 00857031002547 | K171078 | 000 |