WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
FDA 510(k) clearance K023889 · decided 2004-02-11
Clearance details
- K-number
- K023889
- Device name
- WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
- Applicant
- Wiener Laboratories Saic
- Decision
- Substantially Equivalent
- Date received
- 2002-11-21
- Decision date
- 2004-02-11
- Days to decision
- 447 days
- Clearance type
- Traditional
- Product code
- MIU
- Device class
- 1
- Regulation number
- 866.3870
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Rosario, Santa Fe, AR
- 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 |
|---|---|---|
| Chagas Detect Plus Rapid Test (K161947) | InBios International, Inc. | 2016-12-16 |
| ORTHO T. CRUZI ELISA TEST SYSTEM (K072732) | Ortho-Clinical Diagnostics, Inc. | 2009-04-15 |
| HEMAGEN CHAGAS' KIT (EIA METHOD) (K930272) | Hemagen Diagnostics, Inc. | 1995-05-19 |
| ABBOTT CHAGAS ANTIBODY EIA (K933716) | Abbott Laboratories | 1994-12-19 |
| CHAGAS' IGG ELISA TEST (K911233) | Gull Laboratories, Inc. | 1992-05-04 |
Recalls involving this device
No recalls on record reference this clearance.