Total Protein Reagent Set
FDA 510(k) K855191 · Technostics Intl.
510(k) numberK855191
Submission
- Device name
- Total Protein Reagent Set
- Applicant
- Technostics Intl.
Washington, MI, US - Received
- December 26, 1985
- Decision date
- January 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEK – Biuret (Colorimetric), Total Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1635
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992846 | Hichem Total Protein ReagentCEK · Traditional | Elan Holdings, Inc. | 10/18/1999SE |
| K973108 | Total Protein (Micro) Assay, Catalogue Number 450-50CEK · Traditional | Diagnostic Chemicals , Ltd. | 03/02/1998SE |
| K980042 | Careside Total ProteinCEK · Traditional | Exigent Diagnostics, Inc. | 02/04/1998SE |
| K971524 | Total Protein or TPCEK · Traditional | Carolina Liquid Chemistries Corp. | 05/16/1997SE |
| K961864 | Csf/Urine Total ProteinCEK · Traditional | Teco Diagnostics | 10/24/1996SE |
| K955905 | STC Diagnostics Auto-Lyte Urinary Protein AssayCEK · Traditional | Solarcare Technologies Corp,Inc. | 05/30/1996SE |
| K955936 | Total Protein ReagentCEK · Traditional | Derma Media Lab., Inc. | 03/12/1996SE |
| K950920 | Dupont Dimension Total Protein MethodCEK · Traditional | Dupont Medical Products | 08/11/1995SE |
| K950234 | Total Protein Test (Tpro) Item Number: XXXXX/R1. R2CEK · Traditional | Emd Chemicals, Inc. | 06/14/1995SE |
| K950128 | Total Protein Test (Tpro) Item XXXXX/R1. R2CEK · Traditional | Emd Chemicals, Inc. | 05/15/1995SE |
More from Emd Chemicals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K855188 | CPK (UV) Reagent KitJHS · Traditional | 03/05/1986SE |
| K860111 | Uric Acid Reagent SetLFQ · Traditional | 02/19/1986SE |
| K855190 | Magnesium Reagent SetJGJ · Traditional | 02/18/1986SE |
| K860110 | Glutamic Pyruvic Transaminase, Gpt(Uv) Reagent SetCKA · Traditional | 02/11/1986SE |
| K860109 | Enzymatic Urea Nitrogen Reagent SetCDQ · Traditional | 02/06/1986SE |
| K860112 | Total Lipids Reagent SetCFD · Traditional | 01/24/1986SE |
| K855185 | Glucose Reagent SetCGE · Traditional | 01/22/1986SE |
| K855157 | Lactic Dehydrogenase (VV) Reagent SetCFJ · Traditional | 01/21/1986SE |
| K855195 | Direct & Total Bilirubin SetCIG · Traditional | 01/14/1986SE |
| K855194 | Glucose Oxidase Reagent SetCGA · Traditional | 01/14/1986SE |
Questions and answers
When was Total Protein Reagent Set cleared by the FDA?
Total Protein Reagent Set (K855191) received a 510(k) decision of Substantially Equivalent on January 14, 1986, 19 days after the submission was received.
What is the product code of K855191?
The FDA product code is CEK – Biuret (Colorimetric), Total Protein, a Class II (moderate risk) device regulated under 21 CFR 862.1635.