510(k) K963135
- Device
- GIARDIA CELISA
- Applicant
- TECHLAB, INC.
- 510(k) number
- K963135
- Product code
- MHI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-11-29
- Date received
- 1996-08-12
- Regulation
- 866.3220
- Classification name
- Giardia Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID M LYERLY, PH.D.
- Address
- 1861 Pratt Dr. Corporate Research Center Blacksburg VA US 24060 24060
FDA Registration Numbers#
- 3022178699
- 2013736
- 3004569406
- 2029372
- 3002800697
- 8010096
- 3005360469
- 2031468
- 1924669
- 1524213
- 1122855
- 3009935129
- 3017772438
- 2030538
- 3024463179
- 2245285
- 2032839
- 3003750284
Source Documents#
Other 510(k) Records For Product Code MHI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K120001 | UNIGOLD GIARDIA | Trinity Biotech | 2013-03-01 |
| K103673 | GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK | Techlab Inc., Corporate Research Center | 2011-08-18 |
| K081064 | GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF | Ivd Research, Inc. | 2009-01-14 |
| K031942 | XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 | Remel, Inc. | 2003-11-18 |
| K031834 | XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY | Remel, Inc. | 2003-11-10 |
| K033274 | GIARDIA II | Techlab, Inc. | 2003-11-04 |
| K024113 | IVD CRYPTO/GIARDIA DFA | Ivd Research, Inc. | 2003-03-05 |
| K020583 | IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 | Ivd Research, Inc. | 2002-09-17 |
| K983399 | GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY | Genzyme Diagnostics | 1999-01-11 |
| K982711 | PREMIER GIARDIA | Meridian Diagnostics, Inc. | 1998-11-25 |
| K982245 | TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA | Biosite Incorporated | 1998-10-06 |
| K955897 | CRYPTO/GIARDIA-CEL IF TEST | Techlab, Inc. | 1996-08-05 |
| K955157 | PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY | Alexon Biomedical, Inc. | 1996-02-09 |
| K952467 | TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) | Trend Scientific, Inc. | 1995-11-20 |
| K953284 | TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM | Trend Scientific, Inc. | 1995-10-06 |
Legacy Summary#
summary
FDA Review#
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