ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS
FDA 510(k) clearance K102699 · decided 2011-04-01
Clearance details
- K-number
- K102699
- Device name
- ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2010-09-20
- Decision date
- 2011-04-01
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- LCD
- 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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| Record | Firm | Date |
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| ARCHITECT iGentamicin (K243500) | Abbott Laboratories | 2025-07-09 |
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| ROCHE ONLINE GENTAMICIN (K020704) | Roche Diagnostics Corp. | 2002-07-12 |
| RANDOX GENTAMICIN (K012978) | Randox Laboratories, Ltd. | 2001-09-18 |
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| EMIT 2000 GENTAMICIN PLUS ASSAY (K010984) | Syva Co., Dade Behring, Inc. | 2001-04-20 |
| GENTAMICIN FLEX REAGENT CARTRIDGE (K962819) | Dade Intl., Inc. | 1996-09-13 |
| EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS (K962519) | Behring Diagnostics, Inc. | 1996-09-04 |
| ACS GENTAMICIN (K953020) | Ciba Corning Diagnostics Corp. | 1995-08-02 |
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| AXSYM GENTAMICIN (K935376) | Abbott Mfg., Inc. | 1994-06-21 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in t recall (Z-2117-2020) | Abbott Gmbh & Co. KG | 2020-05-12 |
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 |