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 |