The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Giardia Guard.
Device ID | K842052 |
510k Number | K842052 |
Device Name: | GIARDIA GUARD |
Classification | Device, General Purpose, Microbiology, Diagnostic |
Applicant | GELMAN SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LIB |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-22 |
Decision Date | 1984-09-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() GIARDIA GUARD 75520769 2283112 Dead/Cancelled |
Karnes, Tami S. 1998-07-17 |
![]() GIARDIA GUARD 73477806 1370007 Dead/Cancelled |
GELMAN SCIENCES INC. 1984-04-30 |