DeviceClearance

Product code JTS— Hematology

BACTIDROP CALCOFLUOR WHITE

Classification name
Stains, Microbiologic
Device class
Class 1
Regulation
21 CFR 864.1850
Advisory panel
Hematology
Total cleared
40
First cleared
Most recent

Market context for product code JTS

FDA has cleared 40 devices under product code JTS between 1978 and 1996, filed by 19 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code JTS

Recent clearances under product code JTS

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