The following data is part of a premarket notification filed by Trend Scientific, Inc. with the FDA for Trend Giardia Lamblia Direct Detection System (modified Kit).
Device ID | K952467 |
510k Number | K952467 |
Device Name: | TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) |
Classification | Giardia Spp. |
Applicant | TREND SCIENTIFIC, INC. P.O. BOX 12266 New Brighton, MN 55112 -0266 |
Contact | Mariellyn Truax |
Correspondent | Mariellyn Truax TREND SCIENTIFIC, INC. P.O. BOX 12266 New Brighton, MN 55112 -0266 |
Product Code | MHI |
CFR Regulation Number | 866.3220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-26 |
Decision Date | 1995-11-20 |