GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
FDA 510(k) clearance K081064 · decided 2009-01-14
Clearance details
- K-number
- K081064
- Device name
- GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
- Applicant
- Ivd Research, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-04-14
- Decision date
- 2009-01-14
- Days to decision
- 275 days
- Clearance type
- Traditional
- Product code
- MHI
- Device class
- 2
- Regulation number
- 866.3220
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UNIGOLD GIARDIA (K120001) | Trinity Biotech | 2013-03-01 |
| GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK (K103673) | Techlab Inc., Corporate Research Center | 2011-08-18 |
| XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 (K031942) | Remel, Inc. | 2003-11-18 |
| XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY (K031834) | Remel, Inc. | 2003-11-10 |
| GIARDIA II (K033274) | Techlab, Inc. | 2003-11-04 |
| IVD CRYPTO/GIARDIA DFA (K024113) | Ivd Research, Inc. | 2003-03-05 |
| IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 (K020583) | Ivd Research, Inc. | 2002-09-17 |
| GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY (K983399) | Genzyme Diagnostics | 1999-01-11 |
| PREMIER GIARDIA (K982711) | Meridian Diagnostics, Inc. | 1998-11-25 |
| TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA (K982245) | Biosite Incorporated | 1998-10-06 |
| GIARDIA CELISA (K963135) | Techlab, Inc. | 1996-11-29 |
| CRYPTO/GIARDIA-CEL IF TEST (K955897) | Techlab, Inc. | 1996-08-05 |
Recalls involving this device
No recalls on record reference this clearance.