Urine/Csf Microprotein Reagent
FDA 510(k) K913225 · Intersect Systems, Inc.
510(k) numberK913225
Submission
- Device name
- Urine/Csf Microprotein Reagent
- Applicant
- Intersect Systems, Inc.
Longview, WA, US - Received
- July 19, 1991
- Decision date
- October 11, 1991
- 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.
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|---|---|---|
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| K011692 | Homogeneous Enzymic Homocysteine ReagentLPS · Traditional | 07/25/2001SE |
| K003892 | Total Bilirubin ReagentCIG · Traditional | 02/20/2001SE |
| K983937 | Dual Vial Creatinine ReagentCGX · Traditional | 01/06/1999SE |
| K974833 | Ck-Nac ReagentCGS · Traditional | 02/13/1998SE |
| K941807 | Intersect Systems' Non-Mercuric Chloride ReagentCHG · Traditional | 09/14/1994SE |
| K932888 | Intersect Systems Direct Amylase ReagentJFJ · Traditional | 01/31/1994SE |
| K934039 | Intersect Systems HDL Cholesterol Reagent SetLBR · Traditional | 11/16/1993SE |
| K932267 | Enzymatic CO2 Reagent, ModificationKHS · Traditional | 09/24/1993SE |
Questions and answers
When was Urine/Csf Microprotein Reagent cleared by the FDA?
Urine/Csf Microprotein Reagent (K913225) received a 510(k) decision of Substantially Equivalent on October 11, 1991, 84 days after the submission was received.
What is the product code of K913225?
The FDA product code is CEK – Biuret (Colorimetric), Total Protein, a Class II (moderate risk) device regulated under 21 CFR 862.1635.