Biuret Reagent & Total Protein Blank Sol
FDA 510(k) K802161 · Panmed, Inc.
510(k) numberK802161
Submission
- Device name
- Biuret Reagent & Total Protein Blank Sol
- Applicant
- Panmed, Inc.
Mchenry, IL, US - Received
- September 8, 1980
- Decision date
- October 10, 1980
- 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 |
|---|---|---|
| K852767 | Erythocyte CreatineJLA · Traditional | 11/13/1986SE |
| K820642 | Sickle-CheckGHM · Traditional | 04/14/1982SE |
| K802164 | 8-HYDROXYQUINOLINE, Cresolphthalein Com.CIC · Traditional | 10/10/1980SE |
| K802163 | Chloride Color & Chloride Sample DiluentCHJ · Traditional | 10/10/1980SE |
| K802162 | CO2 Color Reagent & CO2 Sample DiluentKMS · Traditional | 10/10/1980SE |
| K802160 | Bun Color Reagent & Bun Acid UsedCDW · Traditional | 10/10/1980SE |
| K802159 | Ammonium Molybdate Inorganic PhosphorusCEO · Traditional | 10/10/1980SE |
| K802158 | Postassium Buffer Sol. & Wash SolutionCEM · Traditional | 10/10/1980SE |
| K802157 | BCG Reagent Serum Albumin W/TechniconCIX · Traditional | 10/10/1980SE |
| K802156 | Reagents Serum Creatine Using TechiconCGX · Traditional | 10/10/1980SE |
Questions and answers
When was Biuret Reagent & Total Protein Blank Sol cleared by the FDA?
Biuret Reagent & Total Protein Blank Sol (K802161) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 32 days after the submission was received.
What is the product code of K802161?
The FDA product code is CEK – Biuret (Colorimetric), Total Protein, a Class II (moderate risk) device regulated under 21 CFR 862.1635.