Product code JPD
- Device name
- Hemoglobin A2 Quantitation
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7400
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE | Tosoh Medics, Inc. | 2002-05-14 |
| K991127 | VARIANT II B-THALASSEMIA | Bio-Rad | 1999-06-10 |
| K924122 | VARIANT BETA-THALASSEMIA SHORT PROGRAM | Bio-Rad | 1993-03-11 |
| K924496 | GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT | Drew Scientific , Ltd. | 1992-11-16 |
| K923317 | COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL | Helena Laboratories | 1992-08-25 |
| K923318 | COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL | Helena Laboratories | 1992-08-25 |
| K913384 | COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 | Helena Laboratories | 1991-12-17 |
| K896168 | HEMOGLOBIN A2 MICRO COLUMN TEST | Bio-Rad | 1990-01-18 |
| K875102 | DETER. OF HEMOGLOBIN A2 USING THE DIAMAT | Bio-Rad | 1988-02-24 |
| K823870 | BETA THALQUIK COLUMN #5341 | Helena Laboratories | 1983-02-01 |
| K812077 | HELENA SICKLE-THAL QUIK COLUMN METHOD | Helena Laboratories | 1981-08-18 |
| K803108 | HELENA HBA2 QUIK COLUMN METHOD | Helena Laboratories | 1981-01-09 |
| K801410 | HEMOHLOBIN A2 CONTROL-LYOPHILIZED | Isolab, Inc. | 1980-07-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04560189283114 | TSKgel G7 β-Thal. HSi | TOSOH CORPORATION | 2016-09-24 |
| 04560189283503 | G7 Beta-Thalassemia Elution Buffer Kit | TOSOH CORPORATION | 2016-09-24 |
| 04560189283664 | Hemoglobin F&A2 Calibrator | TOSOH CORPORATION | 2016-09-24 |
| 04560189283671 | Hemoglobin F&A2 Control Set | TOSOH CORPORATION | 2016-09-24 |
| 00847817012303 | VARIANT II B-thalassemia | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817010606 | Whole Blood Primer | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817009914 | VARIANT II B-thalassemia | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817009204 | VARIANT II B-thalassemia | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817008634 | VARIANT II B-thalassemia | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817008610 | VARIANT II B-thalassemia | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817003462 | D-10 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817000805 | VARIANT II B-thalassemia | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817000447 | VARIANT II B-thalassemia | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817000096 | D-10 Dual | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817012273 | VARIANT II / VARIANT II TURBO | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817003509 | D-10 Dual | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817003455 | D-10 Dual | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817003448 | D-10 Dual | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817003301 | D-10 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| M52553410 | Beta-Thal HbA2 Quik Column Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553340 | Sickle-Thal Quik Column Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |