G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
FDA 510(k) clearance K020489 · decided 2002-05-14
Clearance details
- K-number
- K020489
- Device name
- G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
- Applicant
- Tosoh Medics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-13
- Decision date
- 2002-05-14
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JPD
- Device class
- 2
- Regulation number
- 864.7400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- South San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| VARIANT II B-THALASSEMIA (K991127) | Bio-Rad | 1999-06-10 |
| VARIANT BETA-THALASSEMIA SHORT PROGRAM (K924122) | Bio-Rad | 1993-03-11 |
| GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT (K924496) | Drew Scientific , Ltd. | 1992-11-16 |
| COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL (K923317) | Helena Laboratories | 1992-08-25 |
| COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL (K923318) | Helena Laboratories | 1992-08-25 |
| COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 (K913384) | Helena Laboratories | 1991-12-17 |
| HEMOGLOBIN A2 MICRO COLUMN TEST (K896168) | Bio-Rad | 1990-01-18 |
| DETER. OF HEMOGLOBIN A2 USING THE DIAMAT (K875102) | Bio-Rad | 1988-02-24 |
| BETA THALQUIK COLUMN #5341 (K823870) | Helena Laboratories | 1983-02-01 |
| HELENA SICKLE-THAL QUIK COLUMN METHOD (K812077) | Helena Laboratories | 1981-08-18 |
| HELENA HBA2 QUIK COLUMN METHOD (K803108) | Helena Laboratories | 1981-01-09 |
| HEMOHLOBIN A2 CONTROL-LYOPHILIZED (K801410) | Isolab, Inc. | 1980-07-21 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 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 |
| Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Mfr. By: Tosoh Bioscience, recall (Z-3030-2011) | Tosoh Bioscience Inc | 2011-08-17 |