Product Code: JRJ FDA class 1 21 CFR 862.2050

Unit, Drying

Clinical Chemistry

The Unit, Drying is a clinical laboratory device used to remove moisture from specimens, reagents, or laboratory equipment by controlled drying processes, supporting sample preparation and the preservation of analytical materials used in clinical chemistry testing. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JRJ and is regulated under 21 CFR 862.2050, within the Clinical Chemistry medical specialty. This device is GMP exempt.

510(k)s
1
FEI Numbers
24
Registration Numbers
24
Unique Applicants
1
Years Active

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Basic Information

Product Code
JRJ
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

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
K791077 BECKMAN ELECTROPHORESIS OVEN/INCUBATOR

FEI Numbers

This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.