Microtitrator, For Clinical Use
The Microtitrator, For Clinical Use is a clinical laboratory instrument designed to accurately deliver and titrate very small volumes of liquid samples or reagents in microtiter format, used in clinical chemistry, serology, and microbiology assays to improve precision and reduce specimen and reagent consumption. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JRA and is regulated under 21 CFR 862.2680, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JRA
- Device Class
- FDA class 1
- Regulation Number
- 862.2680
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K963268 | GENESIS RMP | Mar 18, 1997 | Substantially Equivalent | Tecan U.S., Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.