Linical Protein III Calibration Verifiers Levels A-E for Beckman Array Protein System
FDA 510(k) K953926 · International Enzymes, Inc.
510(k) numberK953926
Submission
- Device name
- Linical Protein III 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
- DCK – C-Reactive Protein, Antigen, Antiserum, And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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| 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 III Calibration Verifiers Levels A-E for Beckman Array Protein System cleared by the FDA?
Linical Protein III Calibration Verifiers Levels A-E for Beckman Array Protein System (K953926) 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 K953926?
The FDA product code is DCK – C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.