Product code JMB— Hematology

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Classification name
Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase
Device class
Class 2
Regulation
21 CFR 864.7360
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

Market context for product code JMB

FDA has cleared 1 device under product code JMB, all in 1985, filed by 1 applicant company. 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.

Top applicants under product code JMB

Recent clearances under product code JMB

Data sourced from openFDA. This site is unofficial and independent of the FDA.