JPD — Hemoglobin A2 Quantitation Class II
FDA product code JPD covers "Hemoglobin A2 Quantitation", a Class II medical device regulated under 21 CFR 864.7400. Submissions are reviewed by the Hematology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JPD
- Device Class
- Class II
- Regulation Number
- 864.7400
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K020489 | tosoh medics | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE | May 14, 2002 |
| K991127 | bio-rad | VARIANT II B-THALASSEMIA | June 10, 1999 |
| K924122 | bio-rad | VARIANT BETA-THALASSEMIA SHORT PROGRAM | March 11, 1993 |
| K924496 | drew scientific | GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT | November 16, 1992 |
| K923318 | helena laboratories | COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL | August 25, 1992 |
| K923317 | helena laboratories | COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL | August 25, 1992 |
| K913384 | helena laboratories | COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 | December 17, 1991 |
| K896168 | bio-rad | HEMOGLOBIN A2 MICRO COLUMN TEST | January 18, 1990 |
| K875102 | bio-rad | DETER. OF HEMOGLOBIN A2 USING THE DIAMAT | February 24, 1988 |
| K823870 | helena laboratories | BETA THALQUIK COLUMN #5341 | February 1, 1983 |
| K812077 | helena laboratories | HELENA SICKLE-THAL QUIK COLUMN METHOD | August 18, 1981 |
| K803108 | helena laboratories | HELENA HBA2 QUIK COLUMN METHOD | January 9, 1981 |
| K801410 | isolab | HEMOHLOBIN A2 CONTROL-LYOPHILIZED | July 21, 1980 |