Product Code: JCB FDA class 1 21 CFR 864.4010

Detergent

Pathology

A laboratory detergent is a cleaning and reagent-grade surfactant solution used in clinical and research pathology laboratories for washing equipment, glassware, and specimens, ensuring removal of contaminants that could interfere with diagnostic procedures. It is classified as FDA Class 1, the lowest risk designation, and is exempt from Good Manufacturing Practice requirements as well as premarket notification. The product code is JCB, regulated under 21 CFR 864.4010, within the Pathology medical specialty. This device is GMP exempt.

510(k)s
0
FEI Numbers
44
Registration Numbers
44
Unique Applicants
0
Years Active

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Basic Information

Product Code
JCB
Device Class
FDA class 1
Regulation Number
864.4010
Medical Specialty
Pathology
Review Panel
PA
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

FEI Numbers

This FDA classification entry is associated with 44 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 44 registration numbers. Click on an entry to view related FDA registrations.