Olyumpus Total Protein Reagent
FDA 510(k) K924659 · Olympus Corp.
510(k) numberK924659
Submission
- Device name
- Olyumpus Total Protein Reagent
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- September 15, 1992
- Decision date
- December 29, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K072643 | Crystaleye Spectrophotometer/Crystaleye Basic Set, Model CE100-DC/USKZN · Traditional | 11/16/2007SE |
| K043128 | Olympus EndoarmGWG · Traditional | 12/21/2004SE |
| K042140 | Olympus BF Type UC160-OL8ODG · Traditional | 08/18/2004SE |
| K041494 | Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery UCES-2)…FET · Special | 07/01/2004SE |
| K040940 | Bronchovideoscope Olympus XBF-D160HMEOQ · Traditional | 04/19/2004SE |
| K915402 | EW-10 and EW-20FEB · Traditional | 06/23/1995SN |
| K933200 | Olympus PBD StentsFGE · Traditional | 04/05/1995SE |
| K942338 | Olympus PF-8P Oes Pancreato Fiberscope and AccessoriesFDT · Traditional | 11/30/1994SE |
| K931763 | Hf-Resection Electrode, Loop W/Runner Endos/AccessFAS · Traditional | 08/29/1994SE |
| K934835 | FlovalFJL · Traditional | 06/21/1994SE |
Questions and answers
When was Olyumpus Total Protein Reagent cleared by the FDA?
Olyumpus Total Protein Reagent (K924659) received a 510(k) decision of Substantially Equivalent on December 29, 1992, 105 days after the submission was received.
What is the product code of K924659?
The FDA product code is CEK – Biuret (Colorimetric), Total Protein, a Class II (moderate risk) device regulated under 21 CFR 862.1635.