The following data is part of a premarket notification filed by Trend Scientific, Inc. with the FDA for Fekal Check Parasitology Control Slide.
Device ID | K862914 |
510k Number | K862914 |
Device Name: | FEKAL CHECK PARASITOLOGY CONTROL SLIDE |
Classification | Kit, Quality Control For Culture Media |
Applicant | TREND SCIENTIFIC, INC. P.O. BOX 12266 New Brighton, MN 55112 -0266 |
Contact | Dan Tierney |
Correspondent | Dan Tierney TREND SCIENTIFIC, INC. P.O. BOX 12266 New Brighton, MN 55112 -0266 |
Product Code | JTR |
CFR Regulation Number | 866.2480 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-01 |
Decision Date | 1986-09-16 |