510(k) K971182
- Device
- TOX A/B TEST
- Applicant
- TECHLAB, INC.
- 510(k) number
- K971182
- Product code
- LLH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-07-22
- Date received
- 1997-03-31
- Regulation
- 866.2660
- Classification name
- Reagents, Clostridium Difficile Toxin
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID M LYERLY
- Address
- 1861 Pratt Dr. Corporate Research Center Blacksburg VA US 24060 24060
FDA Registration Numbers#
- 8010096
- 3005360469
- 3021090658
- 3002792284
- 1122855
- 3004530258
- 2013736
- 9615056
- 1524213
- 3024463179
- 3016838963
- 1924669
- 3016733849
- 3033751096
- 3006440892
- 2024674
- 3033507883
- 2032839
- 3009171251
- 3014684020
- 3009935129
- 8020790
- 3026664926
- 3003750284
Source Documents#
Other 510(k) Records For Product Code LLH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193490 | SensiTox C. difficile Toxin Test | First Light Diagnostics, Inc. | 2021-07-08 |
| K102242 | OSOM C. DIFFICILE TOXIN A/B TEST | Genzyme Corporation | 2010-12-21 |
| K091109 | XPERT C. DIFFICILE | Cepheid | 2009-07-09 |
| K090239 | PROGASTRO CD ASSAY | Prodesse, Inc. | 2009-04-16 |
| K082499 | C. DIFF QUIK CHEK COMPLETE | Techlab, Inc. | 2009-03-26 |
| K081920 | BD GENEOHM CDIFF ASSAY | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008-12-19 |
| K080931 | VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY | bioMerieux, Inc. | 2008-06-11 |
| K072138 | VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 | bioMerieux, Inc. | 2007-12-21 |
| K050891 | TOX A/B QUICK CHEK | Techlab, Inc. | 2005-07-25 |
| K041951 | XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B | Remel, Inc. | 2004-11-15 |
| K041003 | IMMUNOCARD TOXINS A & B, MODEL 712050 | Meridian Bioscience, Inc. | 2004-08-20 |
| K032897 | C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 | Ivd Research, Inc. | 2004-05-27 |
| K033479 | PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY | Remel, Inc. | 2004-02-26 |
| K030991 | C. DIFF CHEK - 30 | Techlab, Inc. | 2003-07-11 |
| K030992 | C. DIFF CHEK - 60 | Techlab, Inc. | 2003-07-11 |
Legacy Summary#
summary
FDA Review#
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