Linical Protein I Calibration Verifiers Levels a - E
FDA 510(k) K944486 · International Enzymes, Inc.
510(k) numberK944486
Submission
- Device name
- Linical Protein I Calibration Verifiers Levels a - E
- Applicant
- International Enzymes, Inc.
Fallbrook, CA, US - Received
- September 13, 1994
- Decision date
- December 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
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More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
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| K963085 | Liquid Immunology Control Level I, II, IIIJJX · Traditional | 08/20/1996SE |
| K953927 | Linical Protein Vi Calibration Verifiers Levels A-E for Beckman Array Protein SystemDCF · Traditional | 09/15/1995SE |
| 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 |
Questions and answers
When was Linical Protein I Calibration Verifiers Levels a - E cleared by the FDA?
Linical Protein I Calibration Verifiers Levels a - E (K944486) received a 510(k) decision of Substantially Equivalent on December 2, 1994, 80 days after the submission was received.
What is the product code of K944486?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.