FDA product code MRV: Drink, Glucose Tolerance
MRV is the FDA product code for drink, glucose tolerance. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under MRV, from 3 different applicants. The average 510(k) review took 99 days (median 77). FDA has posted 3 recalls for MRV devices.
Classification
| Field | Value |
|---|---|
| Device name | Drink, Glucose Tolerance |
| Device class | Class II |
| Regulation | 21 CFR 862.1345 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MRV clearance
Top MRV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vineland Syrup, Inc. | 1 | 2012-06-21 |
| Ever Scientific | 1 | 2004-10-27 |
| Perk Scientific, Inc. | 1 | 2003-11-18 |
Most recent MRV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K120247 | Vineland Syrup, Inc. | EASYDEX | 2012-06-21 | 146 |
| K042183 | Ever Scientific | GLUCOSE TOLERANCE BEVERAGE | 2004-10-27 | 77 |
| K032753 | Perk Scientific, Inc. | GLUCOSE TOLERANCE BEVERAGE | 2003-11-18 | 74 |
Recalls for MRV devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-08-24.
Frequently asked questions
What is FDA product code MRV?
MRV is the FDA product code for drink, glucose tolerance. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel.
What device class is MRV?
Class II, regulation 21 CFR 862.1345. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MRV?
Across 3 cleared submissions the average was 99 days from receipt to decision (median 77).
Which companies have the most MRV clearances?
Vineland Syrup, Inc. (1); Ever Scientific (1); Perk Scientific, Inc. (1).
Have MRV devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2016-08-24.
Next steps
- Run an FDA pathway report with predicate devices for product code MRV
- Run a recall and safety report across every MRV manufacturer
- Watch product code MRV 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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