Product Code: JBS FDA class 1 21 CFR 862.2050

Timer, General Laboratory

Clinical Chemistry

A general laboratory timer is a timing device used in clinical and research laboratory settings to measure elapsed time during analytical procedures, sample incubations, and other timed steps in laboratory protocols. It is classified as FDA Class 1, the lowest risk designation, subject only to general controls, and is exempt from Good Manufacturing Practice (GMP) requirements as well as premarket notification. The product code is JBS, regulated under 21 CFR 862.2050, within the Clinical Chemistry medical specialty. This device is GMP exempt.

510(k)s
0
FEI Numbers
11
Registration Numbers
11
Unique Applicants
0
Years Active

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Basic Information

Product Code
JBS
Device Class
FDA class 1
Regulation Number
862.2050
Medical Specialty
Clinical Chemistry
Review Panel
CH
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 11 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.