Connect. Diag. Total Protein Diag. Reage
FDA 510(k) K792340 · Connecticut Diagnostics, Ltd.
510(k) numberK792340
Submission
- Device name
- Connect. Diag. Total Protein Diag. Reage
- Applicant
- Connecticut Diagnostics, Ltd.
Mchenry, IL, US - Received
- November 19, 1979
- Decision date
- December 6, 1979
- 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 |
|---|---|---|
| K905617 | Visi-StaphJWX · Traditional | 03/29/1991SE |
| K822504 | CDL Auto-Lysing ReagentGGK · Traditional | 09/17/1982SE |
| K822501 | CDL Isotonic DiluentGIF · Traditional | 09/17/1982SE |
| K822500 | CDL Lysing ReagentGGK · Traditional | 09/17/1982SE |
| K811222 | Inorganic Phosphorus ReagentsCED · Traditional | 05/21/1981SE |
| K801898 | Uric Acid Diagnostic ReagentKNK · Traditional | 10/10/1980SE |
| K801897 | Glucose Diagnostic ReagentCGA · Traditional | 10/10/1980SE |
| K792465 | Connecticut Diagnostics, Lts. DirectCIG · Traditional | 12/18/1979SE |
| K792362 | Blood Urea Nitrogen ReagentJGZ · Traditional | 12/06/1979SE |
| K792339 | Connect. Diag. Albumin Diagnostic ReagenCIX · Traditional | 12/06/1979SE |
Questions and answers
When was Connect. Diag. Total Protein Diag. Reage cleared by the FDA?
Connect. Diag. Total Protein Diag. Reage (K792340) received a 510(k) decision of Substantially Equivalent on December 6, 1979, 17 days after the submission was received.
What is the product code of K792340?
The FDA product code is CEK – Biuret (Colorimetric), Total Protein, a Class II (moderate risk) device regulated under 21 CFR 862.1635.