Turbidimetric, Total Protein
Turbidimetric Total Protein is a clinical chemistry test system that quantifies total protein in biological specimens by measuring turbidity produced when proteins form precipitates with reagents, supporting nutritional and hepatic status assessment. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JGQ, regulated under 21 CFR 862.1635, within the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JGQ
- Device Class
- FDA class 2
- Regulation Number
- 862.1635
- 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 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K131051 | HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) | Jun 07, 2013 | Substantially Equivalent | Hitachi Chemical Diagnostics, Inc. |
| K072638 | ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 | Oct 19, 2007 | Substantially Equivalent | Roche Diagnostics Corp. |
| K071239 | TOTAL PROTEIN URINE/CSF GEN.3 | Sep 14, 2007 | Substantially Equivalent | Roche Diagnostics |
| K981295 | UPRO | Oct 01, 1998 | Substantially Equivalent | Abbott Laboratories |
| K981682 | UPRO | Sep 21, 1998 | Substantially Equivalent | Abbott Laboratories |
| K925794 | TRACE MICROPROTEIN REAGENT | Mar 29, 1993 | Substantially Equivalent | Trace America, Inc. |
| K913615 | URINARY/CSF PROTEIN | Sep 13, 1991 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K903914 | PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK | Oct 03, 1990 | Substantially Equivalent | Baxter Healthcare Corp |
| K901083 | EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 | Apr 16, 1990 | Substantially Equivalent | Em Diagnostic Systems, Inc. |
| K863478 | CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 | Oct 29, 1986 | Substantially Equivalent | Em Diagnostic Systems, Inc. |
| K842134 | SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY | Jul 06, 1984 | Substantially Equivalent | Somas Medical Industries, Inc. |
| K822231 | ACA URINARY PROTEIN ANALYTICAL TEST PACK | Sep 30, 1982 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K780110 | CSF TOTAL PROTEIN TEST SET #0340 | Mar 03, 1978 | Substantially Equivalent | Stanbio Laboratory |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.