G7 AUTOMATED HPLC ANALYZER
FDA 510(k) clearance K011434 · decided 2001-09-18
Clearance details
- K-number
- K011434
- Device name
- G7 AUTOMATED HPLC ANALYZER
- Applicant
- Tosoh Medics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-10
- Decision date
- 2001-09-18
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- South San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin A recall (Z-2066-2015) | Tosoh Bioscience, Inc. | 2015-07-14 |
| G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemogl recall (Z-1075-2013) | Tosoh Bioscience Inc | 2013-04-10 |