Block, Heating
The Block, Heating is a clinical laboratory device consisting of a temperature-controlled metal block with wells or positions to hold sample tubes or reaction vessels at a controlled temperature, used to incubate specimens and reagents during clinical chemistry assay procedures. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JRG and is regulated under 21 CFR 862.2050, within the Clinical Chemistry medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- JRG
- Device Class
- FDA class 1
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K823766 | BLOOD GAS INCUBATOR #260650 | Feb 18, 1983 | Substantially Equivalent | Boekel Industries, Inc. |
| K790549 | HEATING BLOCK, WAMPOLE 37 C | May 03, 1979 | Substantially Equivalent | Armkel, LLC |
| K781501 | ENZAC INCUBATOR | Oct 03, 1978 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.