Dupont Dimension Total Protein Method
FDA 510(k) K950920 · Dupont Medical Products
510(k) numberK950920
Submission
- Device name
- Dupont Dimension Total Protein Method
- Applicant
- Dupont Medical Products
Wilmington, DE, US - Received
- March 1, 1995
- Decision date
- August 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K943004 | Total Protein QvetCEK · Traditional | Prisma Systems | 12/09/1994SE |
More from Prisma Systems
| 510(k) | Device | Decision |
|---|---|---|
| K952815 | Dupont Lipase CalibratorJIT · Traditional | 08/31/1995SE |
| K952816 | Lipase Flex Reagent CartridgeCHI · Traditional | 07/20/1995SE |
| K952412 | Dupont Aca(R) Urine Druge Os Abuse ControlDIF · Traditional | 06/23/1995SE |
| K945280 | Dupont Dimension C-Reactive Protein MethodDCK · Traditional | 03/09/1995SE |
| K944932 | Phenobarbital Flex Reagent CartridgeDLZ · Traditional | 12/28/1994SE |
| K941050 | Dupont Aca StarJJQ · Traditional | 11/10/1994SE |
| K943996 | Dupont Aca Plus Luteinizing Hormone (LH) MethodCEP · Traditional | 10/20/1994SE |
| K941146 | Dupont Aca Plus Thyroid Stimulating Hormone SystemJLW · Traditional | 10/03/1994SE |
| K942640 | Dupont Dimension Amylase MethodJFJ · Traditional | 09/09/1994SE |
| K942241 | Dupont Apc Blood Collection Container with ThromboplastinJKA · Traditional | 08/18/1994SE |
Questions and answers
When was Dupont Dimension Total Protein Method cleared by the FDA?
Dupont Dimension Total Protein Method (K950920) received a 510(k) decision of Substantially Equivalent on August 11, 1995, 163 days after the submission was received.
What is the product code of K950920?
The FDA product code is CEK – Biuret (Colorimetric), Total Protein, a Class II (moderate risk) device regulated under 21 CFR 862.1635.