Liquizyme Total Protein Reagent
FDA 510(k) K823170 · Amresco, Inc.
510(k) numberK823170
Submission
- Device name
- Liquizyme Total Protein Reagent
- Applicant
- Amresco, Inc.
Mchenry, IL, US - Received
- October 26, 1982
- Decision date
- November 29, 1982
- 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 |
|---|---|---|
| K905618 | GGT ReagentJPZ · Traditional | 02/26/1991SE |
| K904468 | Direct Bilirubin Reagent, 7776/7777/7576/7476/7176CIG · Traditional | 01/17/1991SE |
| K905684 | Alkaline PhosphataseCJE · Traditional | 12/28/1990SE |
| K905544 | Magnesium ReagentJGJ · Traditional | 12/27/1990SE |
| K905284 | Hdl-Cholesterol Precipitant 7773/7573/7473/7173LBR · Traditional | 12/11/1990SE |
| K904004 | Amrescocreat Kinase Reagent 7716/17,7516,7416,7116CGS · Traditional | 12/11/1990SE |
| K905096 | GGT Reagents, 7738, 7739, 7538, 7438 & 7138JQB · Traditional | 11/28/1990SE |
| K904381 | Diazo Colorimentry Direct BilirubinCIG · Traditional | 10/12/1990SE |
| K903775 | Creatine PhosphokinaseCGS · Traditional | 10/04/1990SE |
| K903829 | Ast ReagentCIT · Traditional | 09/25/1990SE |
Questions and answers
When was Liquizyme Total Protein Reagent cleared by the FDA?
Liquizyme Total Protein Reagent (K823170) received a 510(k) decision of Substantially Equivalent on November 29, 1982, 34 days after the submission was received.
What is the product code of K823170?
The FDA product code is CEK – Biuret (Colorimetric), Total Protein, a Class II (moderate risk) device regulated under 21 CFR 862.1635.