VARIANT II B-THALASSEMIA
FDA 510(k) clearance K991127 · decided 1999-06-10
Clearance details
- K-number
- K991127
- Device name
- VARIANT II B-THALASSEMIA
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1999-04-02
- Decision date
- 1999-06-10
- Days to decision
- 69 days
- Clearance type
- Special
- Product code
- JPD
- Device class
- 2
- Regulation number
- 864.7400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Hercules, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE (K020489) | Tosoh Medics, Inc. | 2002-05-14 |
| 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 |
|---|---|---|
| Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 recall (Z-1537-2014) | Bio-Rad Laboratories, Inc. | 2014-05-02 |
| VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determ recall (Z-0023-2012) | Bio-Rad Laboratories, Inc. | 2011-10-07 |
| VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determ recall (Z-0024-2012) | Bio-Rad Laboratories, Inc. | 2011-10-07 |
| VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,. Made in United States. recall (Z-0025-2012) | Bio-Rad Laboratories, Inc. | 2011-10-07 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S002) | Bio-Rad | 1996-03-01 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001) | Bio-Rad | 1991-03-14 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032) | Bio-Rad | 1989-07-24 |