Csf/Urine Total Protein
510(k) K961864
Csf/Urine Total Protein is a Class II device made by Teco Diagnostics, cleared under FDA 510(k) K961864 on 24 Oct 1996, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK961864 | Date24 Oct 1996 | StatusActive |
Official records
- FDA 510(k) database K961864
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CEK
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1635
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K961864
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Teco Diagnostics CSF/Urine Protein Reagent Set P615-480 | P615-480 / P615-480 | 10673486002171 | — | On the market |
Similar devices
Other devices filed under FDA product code CEK (Biuret (Colorimetric), Total Protein).
- STAT KIT, MICROPROTEIN by Pierce Chemical Co.
- TOTAL PROTEIN REAGENT SET by Anco Medical Reagents & Assoc.
- URINARY/CEREBROSPINAL FLUID PROTEIN by E.I. Dupont DE Nemours & Co., Inc.
- COULTER TOTAL PROTEIN REAGENT by Coulter Electronics, Inc.
- BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST by Beckman Instruments, Inc.
- ULTRACHEM TP, ITEM #64974 by Harleco
- KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT) by EASTMAN KODAK COMPANY
- ARCHITECT 04U4430 by ABBOTT IRELAND
- BIURET REAGENT & TOTAL PROTEIN BLANK SOL by Panmed, Inc.
- REAGENT SET, TOTAL PROTEIN by Medical Analysis Systems, Inc.