ABBOTT CHAGAS ANTIBODY EIA
FDA 510(k) clearance K933716 · decided 1994-12-19
Clearance details
- K-number
- K933716
- Device name
- ABBOTT CHAGAS ANTIBODY EIA
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1993-07-30
- Decision date
- 1994-12-19
- Days to decision
- 507 days
- Clearance type
- Traditional
- Product code
- MIU
- Device class
- 1
- Regulation number
- 866.3870
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Abbott Park, IL, 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 |
|---|---|---|
| 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 |
| WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 (K023889) | Wiener Laboratories Saic | 2004-02-11 |
| HEMAGEN CHAGAS' KIT (EIA METHOD) (K930272) | Hemagen Diagnostics, Inc. | 1995-05-19 |
| CHAGAS' IGG ELISA TEST (K911233) | Gull Laboratories, Inc. | 1992-05-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |