CYBREX GENTAMICIN
FDA 510(k) clearance K801084 · decided 1980-05-23
Clearance details
- K-number
- K801084
- Device name
- CYBREX GENTAMICIN
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1980-05-07
- Decision date
- 1980-05-23
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- LCQ
- Device class
- 2
- Regulation number
- 862.3450
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 |
|---|---|---|
| VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM (K972609) | Bio-Rad | 1997-08-06 |
| INNOFLUOR GENTAMICIN ASSAY SYSTEM (K955569) | Oxis Intl., Inc. | 1996-02-09 |
| COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS (K945523) | Roche Diagnostic Systems, Inc. | 1995-03-09 |
| GENTAMICIN FPIA REAGENT SET AND CALIBRATORS (K943550) | Sigma Diagnostics, Inc. | 1994-11-17 |
| OPUS GENTAMICIN (K905721) | Pb Diagnostic Systems, Inc. | 1991-02-21 |
| 'TDXFLX ANALYZER (K904226) | Abbott Laboratories | 1990-10-29 |
| FPR GENTAMICIN KIT (K894523) | Colony Laboratories, Inc. | 1989-09-28 |
| BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA (K852158) | Bioprobe Intl., Inc. | 1985-06-25 |
| GENTAMICIN KIT(FPIA) (K852013) | Windsor Laboratories, Inc. | 1985-06-10 |
| COBAS REAGENTS FOR GENTAMICIN & CALIBRAT (K843827) | Roche Diagnostic Systems, Inc. | 1985-02-01 |
| INNOFLOUR GENTAMICIN (K841865) | Innotron Diagnostics | 1984-05-31 |
| IMMPULSE GENTAMICIN ASSAY REAGENTS (K841162) | Paragon Diagnostics, Inc. | 1984-05-02 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reag recall (Z-0928-2008) | Abbott Diagnostic International, Ltd. | 2008-02-26 |
| Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro diagnostic use. Thi recall (Z-0929-2008) | Abbott Diagnostic International, Ltd. | 2008-02-26 |
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 |