JPD · Class II · 21 CFR 864.7400

FDA Product Code JPD: Hemoglobin A2 Quantitation

Leading manufacturers include Helena Laboratories and Bio-Rad.

13
Total
13
Cleared
75d
Avg days
1980
Since

FDA 510(k) Cleared Hemoglobin A2 Quantitation Devices (Product Code JPD)

13 devices
1–13 of 13
Cleared Jun 10, 1999
VARIANT II B-THALASSEMIA
K991127
Bio-Rad
Hematology · 69d
Cleared Mar 11, 1993
VARIANT BETA-THALASSEMIA SHORT PROGRAM
K924122
Bio-Rad
Hematology · 209d
Cleared Aug 25, 1992
COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL
K923317
Helena Laboratories
Hematology · 49d
Cleared Aug 25, 1992
COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL
K923318
Helena Laboratories
Hematology · 49d
Cleared Dec 17, 1991
COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
K913384
Helena Laboratories
Hematology · 141d
Cleared Jan 18, 1990
HEMOGLOBIN A2 MICRO COLUMN TEST
K896168
Bio-Rad
Hematology · 85d
Cleared Feb 24, 1988
DETER. OF HEMOGLOBIN A2 USING THE DIAMAT
K875102
Bio-Rad
Hematology · 76d
Cleared Feb 01, 1983
BETA THALQUIK COLUMN #5341
K823870
Helena Laboratories
Hematology · 40d
Cleared Aug 18, 1981
HELENA SICKLE-THAL QUIK COLUMN METHOD
K812077
Helena Laboratories
Hematology · 27d
Cleared Jan 09, 1981
HELENA HBA2 QUIK COLUMN METHOD
K803108
Helena Laboratories
Hematology · 30d

About Product Code JPD - Regulatory Context