The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for H. Pylori Quik Chek.
Device ID | K181379 |
510k Number | K181379 |
Device Name: | H. PYLORI QUIK CHEK |
Classification | Helicobacter Pylori |
Applicant | TECHLAB, Inc. 2001 Kraft Drive Corporate Research Center Blacksburg, VA 24060 -6358 |
Contact | Donna T. Link |
Correspondent | Donna T. Link TECHLAB, Inc. 2001 Kraft Drive Corporate Research Center Blacksburg, VA 24060 -6358 |
Product Code | LYR |
CFR Regulation Number | 866.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-24 |
Decision Date | 2018-08-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857031002516 | K181379 | 000 |
00857031002493 | K181379 | 000 |
00857031002561 | K181379 | 000 |
00857031002622 | K181379 | 000 |