FDA product code JGP: Lowry (Colorimetric), Total Protein
JGP is the FDA product code for lowry (colorimetric), total protein. It is a Class II device, regulated under 21 CFR 862.1635 and reviewed by the Clinical Chemistry panel. FDA has cleared 5 510(k) submissions under JGP, from 5 different applicants. The average 510(k) review took 96 days (median 69). FDA has posted 2 recalls for JGP devices.
Classification
| Field | Value |
|---|---|
| Device name | Lowry (Colorimetric), Total Protein |
| Device class | Class II |
| Regulation | 21 CFR 862.1635 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JGP clearance
Top JGP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pointe Scientific, Inc., | 1 | 2007-12-04 |
| Johnson & Johnson Clinical Diagnostics, Inc. | 1 | 1997-02-18 |
| J. D. Assoc. | 1 | 1986-12-10 |
| Biovation, Inc. | 1 | 1982-06-10 |
| Panmed, Inc. | 1 | 1979-12-06 |
Most recent JGP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070757 | Pointe Scientific, Inc., | MICROPROTEIN REAGENT SET | 2007-12-04 | 259 |
| K964960 | Johnson & Johnson Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS UPRO SLIDES | 1997-02-18 | 69 |
| K863112 | J. D. Assoc. | PROTEINMETER | 1986-12-10 | 119 |
| K821534 | Biovation, Inc. | HEMATOLOGY DATA MANAGEMENT SYS | 1982-06-10 | 17 |
| K792347 | Panmed, Inc. | MICRO LOWRY PROTEINTEST | 1979-12-06 | 17 |
Recalls for JGP devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-12-08.
Frequently asked questions
What is FDA product code JGP?
JGP is the FDA product code for lowry (colorimetric), total protein. It is a Class II device, regulated under 21 CFR 862.1635 and reviewed by the Clinical Chemistry panel.
What device class is JGP?
Class II, regulation 21 CFR 862.1635. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JGP?
Across 5 cleared submissions the average was 96 days from receipt to decision (median 69).
Which companies have the most JGP clearances?
Pointe Scientific, Inc., (1); Johnson & Johnson Clinical Diagnostics, Inc. (1); J. D. Assoc. (1); Biovation, Inc. (1); Panmed, Inc. (1).
Have JGP devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2016-12-08.
Next steps
- Run an FDA pathway report with predicate devices for product code JGP
- Run a recall and safety report across every JGP manufacturer
- Watch product code JGP 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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