RESUBMITTED ABBOTT TESTPACK ROTAVIRUS
FDA 510(k) clearance K880821 · decided 1988-05-06
Clearance details
- K-number
- K880821
- Device name
- RESUBMITTED ABBOTT TESTPACK ROTAVIRUS
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1988-03-01
- Decision date
- 1988-05-06
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- LIQ
- Device class
- 1
- Regulation number
- 866.3405
- 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 |
|---|---|---|
| SAS ROTA TEST (K990842) | Sa Scientific, Inc. | 1999-08-09 |
| VIDAS ROTAVIRUS (RTV) ASSAY (K972895) | Biomerieux Vitek, Inc. | 1997-10-03 |
| IMMUNOCARD STAT! ROTAVIRUS (K971585) | Meridian Diagnostics, Inc. | 1997-08-20 |
| ROTAVIRUS EIA (K964424) | Trinity Biotech, Inc. | 1997-08-08 |
| VIDAS ROTAVIRUS ASSAY (K965092) | Biomerieux Vitek, Inc. | 1997-05-05 |
| ROTA-DAN RAPID ROTAVIRUS EIA KIT (K951208) | Eldan Technologies, Ltd. | 1996-02-14 |
| DIARLEX ROTA-ADENO (K942286) | Orion Diagnostica, Inc. | 1994-12-14 |
| IMMUNOCARD ROTAVIRUS (K933587) | Meridian Diagnostics, Inc. | 1994-02-03 |
| IDEIA(TM) ROTAVIRUS (K932384) | Dako Diagnostics , Ltd. | 1993-12-27 |
| KALLESTAD ROTAVIRUS MICROPLATE (K915137) | Bio-Rad Laboratories, Inc. | 1992-03-04 |
| DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 (K912666) | Dako Corp. | 1992-02-14 |
| SLIDEX ROTA-KIT 2 (K895805) | Vitek Systems, Inc. | 1991-02-26 |
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 |