Micro Pipette
The Micro Pipette is a precision clinical laboratory instrument used to aspirate and dispense very small, accurately measured volumes of liquid specimens or reagents in clinical chemistry and other laboratory testing procedures, serving as a fundamental tool for accurate specimen handling and reagent addition. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JRC 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
- JRC
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K840186 | SMI DIGITRON | Apr 05, 1984 | Substantially Equivalent | Scientific Manufacturing Industries |
| K834100 | PRE-CALIBRATED PIPETTES | Feb 21, 1984 | Substantially Equivalent | Vitex |
| K822078 | DADE DISP. DISPENSING-SPREADING PIPETS | Jul 27, 1982 | Substantially Equivalent | American Dade |
| K792696 | MICROPITETTE | Feb 01, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K770594 | LABORATORY EXPENDABLE PRODUCTS | Jul 06, 1977 | Substantially Equivalent | Abco Dealers, Inc. |
| K760621 | LANCER PLASTIC TRANSFER PIPETTE | Oct 05, 1976 | Substantially Equivalent | Sherwood Medical Industries |
FEI Numbers
This FDA classification entry is associated with 93 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 93 registration numbers. Click on an entry to view related FDA registrations.