JPD · Class II · 21 CFR 864.7400

FDA Product Code JPD: Hemoglobin A2 Quantitation

Leading manufacturers include Helena Laboratories, Bio-Rad and Tosoh Medics, Inc..

Total

Cleared

75d

Avg days

1980

Since

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

13 devices

1–13 of 13

Cleared May 14, 2002

G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE

VARIANT II B-THALASSEMIA

VARIANT BETA-THALASSEMIA SHORT PROGRAM

COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL

COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL

COLUMNMATE(TM) BETA-THAL CAT. NO. 4515

HEMOGLOBIN A2 MICRO COLUMN TEST

DETER. OF HEMOGLOBIN A2 USING THE DIAMAT

BETA THALQUIK COLUMN #5341

HELENA SICKLE-THAL QUIK COLUMN METHOD

HELENA HBA2 QUIK COLUMN METHOD

HEMOHLOBIN A2 CONTROL-LYOPHILIZED

K801410

Isolab, Inc.

Hematology · 35d

About Product Code JPD - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,730 total devices indexed.

Latest clearance: May 14, 2002

Product Code Info

Code	JPD
Device class	Class II
CFR	21 CFR 864.7400
Panel	Hematology

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View JPD classification on FDA.gov →