Linical Protein Vi Calibration Verifiers Levels A-E for Beckman Array Protein System
FDA 510(k) K953927 · International Enzymes, Inc.
510(k) numberK953927
Submission
- Device name
- Linical Protein Vi Calibration Verifiers Levels A-E for Beckman Array Protein System
- Applicant
- International Enzymes, Inc.
San Marcos, CA, US - Received
- August 15, 1995
- Decision date
- September 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DCF – Albumin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5040
- Specialty
- Immunology
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| K143118 | Human Microalbumin kit for use on SPAPLUSDCF · Traditional | The Binding Site Group , Ltd. | 05/26/2015SE |
| K142346 | Urine/CSF Albumin, Urine/CSF Albumin CalibratorDCF · Traditional | Beckman Coulter Ireland, Inc. | 10/15/2014SE |
| K121045 | Human Albumin CSF KitDCF · Traditional | The Binding Site Group , Ltd. | 06/19/2013SE |
| K113072 | Tina-Quant Albumin GEN.2DCF · Traditional | Roche Diagnostics Operations | 05/14/2012SE |
| K101089 | Easyra Micro-Albumin Reagent and CalibratorDCF · Traditional | Medica Corp. | 07/13/2011SE |
| K101203 | Tina-Quant Albumin Gen 2DCF · Traditional | Roche Diagnostics | 09/10/2010SE |
| K100853 | Cobas 8000 Modular Series AnalyzerDCF · Special | Roche Diagnostics Corp. | 09/09/2010SE |
| K091486 | K-Assay Microalbumin and K-Assay Microalbumin CalibratorDCF · Traditional | Kamiya Biomedical Co. | 04/29/2010SE |
| K082251 | Synchron Systems Microalbumin (Ma) Reagent, Model 475100DCF · Traditional | Beckman Coulter, Inc. | 04/08/2009SE |
More from Beckman Coulter, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K011169 | Hscrp Control Level 1, Hscrp Control Level 2, and Hscrp Control Level 3JJY · Traditional | 05/18/2001SE |
| K963085 | Liquid Immunology Control Level I, II, IIIJJX · Traditional | 08/20/1996SE |
| K953926 | Linical Protein III Calibration Verifiers Levels A-E for Beckman Array Protein SystemDCK · Traditional | 09/15/1995SE |
| K950802 | Linical Protein I Calibration Verifiers Levels a - for Beckman Array 360 SystemJJY · Traditional | 06/01/1995SE |
| K944513 | Linical Protein Vi Calibration Verifiers Levels A-EJJY · Traditional | 12/02/1994SE |
| K944486 | Linical Protein I Calibration Verifiers Levels a - EJJY · Traditional | 12/02/1994SE |
Questions and answers
When was Linical Protein Vi Calibration Verifiers Levels A-E for Beckman Array Protein System cleared by the FDA?
Linical Protein Vi Calibration Verifiers Levels A-E for Beckman Array Protein System (K953927) received a 510(k) decision of Substantially Equivalent on September 15, 1995, 31 days after the submission was received.
What is the product code of K953927?
The FDA product code is DCF – Albumin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5040.