Roche/Hitachi Urinary/Csf Protein with Model(S) Cat #11877801
FDA 510(k) K072638 · Roche Diagnostics Corp.
510(k) numberK072638
Submission
- Device name
- Roche/Hitachi Urinary/Csf Protein with Model(S) Cat #11877801
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- September 18, 2007
- Decision date
- October 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JGQ – Turbidimetric, Total Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1635
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131051 | Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb)JGQ · Traditional | Hitachi Chemical Diagnostics, Inc. | 06/07/2013SE |
| K071239 | Total Protein Urine/Csf GEN.3JGQ · Special | Roche Diagnostics | 09/14/2007SE |
| K981295 | UproJGQ · Traditional | Abbott Laboratories | 10/01/1998SE |
| K981682 | UproJGQ · Traditional | Abbott Laboratories | 09/21/1998SE |
| K925794 | Trace Microprotein ReagentJGQ · Traditional | Trace America, Inc. | 03/29/1993SE |
| K913615 | Urinary/Csf ProteinJGQ · Traditional | Boehringer Mannheim Corp. | 09/13/1991SE |
| K903914 | Paramax Cerebrospinal Fluid/Urine Protein BlankJGQ · Traditional | Baxter Healthcare Corp | 10/03/1990SE |
| K901083 | Emds(Tm) Cerebrospinal Fluid Protein, #67668/95JGQ · Traditional | Em Diagnostic Systems, Inc. | 04/16/1990SE |
| K863478 | Cerebrospinal Fluid Protein Testpack, #67668/95JGQ · Traditional | Em Diagnostic Systems, Inc. | 10/29/1986SE |
| K842134 | Somas Coomasie Blue Total Protein AssayJGQ · Traditional | Somas Medical Industries, Inc. | 07/06/1984SE |
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Questions and answers
When was Roche/Hitachi Urinary/Csf Protein with Model(S) Cat #11877801 cleared by the FDA?
Roche/Hitachi Urinary/Csf Protein with Model(S) Cat #11877801 (K072638) received a 510(k) decision of Substantially Equivalent on October 19, 2007, 31 days after the submission was received.
What is the product code of K072638?
The FDA product code is JGQ – Turbidimetric, Total Protein, a Class II (moderate risk) device regulated under 21 CFR 862.1635.