HEMOGLOBIN A2 MICRO COLUMN TEST
FDA 510(k) clearance K896168 · decided 1990-01-18
Clearance details
- K-number
- K896168
- Device name
- HEMOGLOBIN A2 MICRO COLUMN TEST
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1989-10-25
- Decision date
- 1990-01-18
- Days to decision
- 85 days
- Clearance type
- Traditional
- 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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| G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE (K020489) | Tosoh Medics, Inc. | 2002-05-14 |
| 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 |
| 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
No recalls on record reference this clearance.
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 |