Product code JPD— Hematology
BETA THALQUIK COLUMN #5341
- Classification name
- Hemoglobin A2 Quantitation
- Device class
- Class 2
- Regulation
- 21 CFR 864.7400
- Advisory panel
- Hematology
- Total cleared
- 13
- First cleared
- Most recent
Market context for product code JPD
FDA has cleared devices under product code JPD between 1980 and 2002, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2002
- 1999
- 1993
- 1992
- 1991
- 1990
- 1988
- 1983
- 1981
- 1980
Top applicants under product code JPD
Recent clearances under product code JPD
- K020489 — G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
- K991127 — VARIANT II B-THALASSEMIA
- K924122 — VARIANT BETA-THALASSEMIA SHORT PROGRAM
- K924496 — GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT
- K923317 — COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL
- K923318 — COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL
- K913384 — COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
- K896168 — HEMOGLOBIN A2 MICRO COLUMN TEST
- K875102 — DETER. OF HEMOGLOBIN A2 USING THE DIAMAT
- K823870 — BETA THALQUIK COLUMN #5341
- K812077 — HELENA SICKLE-THAL QUIK COLUMN METHOD
- K803108 — HELENA HBA2 QUIK COLUMN METHOD
- K801410 — HEMOHLOBIN A2 CONTROL-LYOPHILIZED
Data sourced from openFDA. This site is unofficial and independent of the FDA.