FDA product code JRC: Micro Pipette
JRC is the FDA product code for micro pipette. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 6 510(k) submissions under JRC, from 6 different applicants. The average 510(k) review took 55 days (median 57). FDA has posted 3 recalls for JRC devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Micro Pipette |
| Device class | Class I |
| Regulation | 21 CFR 862.2050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JRC clearance
Top JRC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Scientific Manufacturing Industries | 1 | 1984-04-05 |
| Vitex | 1 | 1984-02-21 |
| American Dade | 1 | 1982-07-27 |
| Meridian Diagnostics, Inc. | 1 | 1980-02-01 |
| Abco Dealers, Inc. | 1 | 1977-07-06 |
1 more applicants have JRC clearances. See the full list in Caduvo.
Most recent JRC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K840186 | Scientific Manufacturing Industries | SMI DIGITRON | 1984-04-05 | 78 |
| K834100 | Vitex | PRE-CALIBRATED PIPETTES | 1984-02-21 | 83 |
| K822078 | American Dade | DADE DISP. DISPENSING-SPREADING PIPETS | 1982-07-27 | 12 |
| K792696 | Meridian Diagnostics, Inc. | MICROPITETTE | 1980-02-01 | 36 |
| K770594 | Abco Dealers, Inc. | LABORATORY EXPENDABLE PRODUCTS | 1977-07-06 | 100 |
Recalls for JRC devices
3 product recalls in 3 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-07-14.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code JRC?
JRC is the FDA product code for micro pipette. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JRC?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JRC?
Across 6 cleared submissions the average was 55 days from receipt to decision (median 57).
Which companies have the most JRC clearances?
Scientific Manufacturing Industries (1); Vitex (1); American Dade (1); Meridian Diagnostics, Inc. (1); Abco Dealers, Inc. (1).
Have JRC devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2023-07-14.
Next steps
- Run an FDA pathway report with predicate devices for product code JRC
- Run a recall and safety report across every JRC manufacturer
- Watch product code JRC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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