TRI-COMBO PARASITE SCREEN
FDA 510(k) clearance K171078 · decided 2017-07-10
Clearance details
- K-number
- K171078
- Device name
- TRI-COMBO PARASITE SCREEN
- Applicant
- Techlab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-04-11
- Decision date
- 2017-07-10
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MHJ
- Device class
- 2
- Regulation number
- 866.3220
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Blacksburg, VA, 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 |
|---|---|---|
| UNI-GOLD CRYPTOSPORIDIUM (K121565) | Trinity Biotech | 2013-02-08 |
| GIARDIA/CRYPTOSPORIDIUM CHEK (K051929) | Techlab, Inc. | 2005-11-17 |
| CRYPTOSPORIDIUM II (K052932) | Techlab, Inc. | 2005-11-04 |
| XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (K031965) | Remel, Inc. | 2003-11-14 |
| IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 (K031059) | Ivd Research, Inc. | 2003-07-10 |
| PREMIER CRYPTOSPORIDIUM (K982764) | Meridian Diagnostics, Inc. | 1998-12-03 |
| MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY (K982709) | Alexon - Trend, Inc. | 1998-09-03 |
| CRYPTOSPORIDIUM TEST (K980354) | Techlab, Inc. | 1998-05-18 |
| CRYPTO-CEL IF TEST (K955852) | Techlab, Inc. | 1996-08-05 |
| TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS (K955755) | Trend Scientific, Inc. | 1996-07-11 |
| LMD CRYPTOSPORIDIUM ANTIGEN DETECTION (K955345) | Lmd Laboratories | 1996-06-07 |
| PROSPECT CRYPTOSPORIDIUM RAPID ASSAY (K936191) | Alexon Biomedical, Inc. | 1994-11-17 |
Recalls involving this device
No recalls on record reference this clearance.