JGP · Lowry (Colorimetric), Total Protein
Clinical Chemistry · 21 CFR 862.1635 · Class 2
Overview
| Product Code | JGP |
|---|---|
| Device Name | Lowry (Colorimetric), Total Protein |
| Regulation | 21 CFR 862.1635 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K070757 | MICROPROTEIN REAGENT SET | Pointe Scientific, Inc., | Dec 4, 2007 | SESE |
| K964960 | VITROS CHEMISTRY PRODUCTS UPRO SLIDES | Johnson & Johnson Clinical Diagnostics, Inc. | Feb 18, 1997 | SESE |
| K863112 | PROTEINMETER | J. D. Assoc. | Dec 10, 1986 | SESE |
| K821534 | HEMATOLOGY DATA MANAGEMENT SYS | Biovation, Inc. | Jun 10, 1982 | SESE |
| K792347 | MICRO LOWRY PROTEINTEST | Panmed, Inc. | Dec 6, 1979 | SESE |
Top Applicants
- Biovation, Inc. — 1 clearance
- J. D. Assoc. — 1 clearance
- Johnson & Johnson Clinical Diagnostics, Inc. — 1 clearance
- Panmed, Inc. — 1 clearance
- Pointe Scientific, Inc., — 1 clearance
