The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Campylobacter Chek.
Device ID | K173219 |
510k Number | K173219 |
Device Name: | CAMPYLOBACTER CHEK |
Classification | Campylobacter 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 | LQP |
CFR Regulation Number | 866.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-03 |
Decision Date | 2018-01-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857031002462 | K173219 | 000 |
00857031002486 | K173219 | 000 |