JPD — Hemoglobin A2 Quantitation Class II
FDA Device Classification
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 |