Product Code: JRM FDA class 1 21 CFR 862.2050

Freezer

Clinical Chemistry

The Freezer (for clinical laboratory use) is a refrigeration device used to store biological specimens, reagents, controls, and calibrators at sub-zero temperatures to preserve their stability and integrity for use in clinical chemistry and other diagnostic testing. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JRM and is regulated under 21 CFR 862.2050, within the Clinical Chemistry medical specialty. This device is GMP exempt.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: JRM
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

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 7 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K921570	ORS-300	Jun 09, 1992	Substantially Equivalent	Mnlase, Inc.
K921569	ORS-200	Jun 09, 1992	Substantially Equivalent	Mnlase, Inc.
K921568	ORS-100	Jun 09, 1992	Substantially Equivalent	Mnlase, Inc.
K915427	ORS-1000	Jan 07, 1992	Substantially Equivalent	Mnlase, Inc.
K913777	SELF-CONTAINED SURGICAL SLUSH FREEZER	Sep 25, 1991	Substantially Equivalent	Taylor Corp.
K894006	SANISERV SURGICAL SLUSH SYSTEM	Nov 03, 1989	Substantially Equivalent	Saniserv, Inc.
K782077	LANCER ICE CUBE	Apr 03, 1979	Substantially Equivalent	Sherwood Medical Industries