Linical Protein 2 Calibration Verifiers Levels A-E for Olympus Au Analyzers
FDA 510(k) K031575 · Cliniqa Corporation
510(k) numberK031575
Submission
- Device name
- Linical Protein 2 Calibration Verifiers Levels A-E for Olympus Au Analyzers
- Applicant
- Cliniqa Corporation
Fallbrook, CA, US - Received
- May 20, 2003
- Decision date
- July 23, 2003
- 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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| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
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| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| 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.
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|---|---|---|
| K120900 | I-Stat PT Control Leviel 1 I-Stat PT Control Level 2GGN · Traditional | 05/31/2013SE |
| K121237 | Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG…JJX · Traditional | 05/18/2012SE |
| K083554 | Cliniqa Liquidqc Immunoassay Control Level 1, 2 & 3JJY · Traditional | 04/21/2009SE |
| K081908 | Cliniqa Liquid QC Urinalysis Controls, Levels 1 and 2JJW · Traditional | 01/16/2009SE |
| K082107 | Cliniqa Liquid QC Urine Chemistry Controls, Levels 1 and 2JJY · Traditional | 09/17/2008SE |
| K080973 | Cliniqa Liquid QC Complete Cardiac Marker Control, Levels 1,2, and 3; Cardiac Marker…JJY · Traditional | 06/02/2008SE |
| K070741 | Cliniqa Liquid QC Unassayed and Assayed General Chemistry Control Levels 1, 2, & 3JJY · Traditional | 05/04/2007SE |
| K062916 | Cliniqa Liquid QC Cardiac Marker Control SP, Levels 1,2, &3JJY · Traditional | 10/23/2006SE |
| K061182 | Cliniqa Liquid QC Lipid Control Levels 1 & 2;LINICAL Lipid Calibration Verifiers Levels…JJY · Traditional | 05/25/2006SE |
| K060322 | Cliniqa Dry QC Chemistry Control, Levels 1 and 2, Assayed, Cliniqa Dry QC Chemistry…JIT · Traditional | 03/21/2006SE |
Questions and answers
When was Linical Protein 2 Calibration Verifiers Levels A-E for Olympus Au Analyzers cleared by the FDA?
Linical Protein 2 Calibration Verifiers Levels A-E for Olympus Au Analyzers (K031575) received a 510(k) decision of Substantially Equivalent on July 23, 2003, 64 days after the submission was received.
What is the product code of K031575?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.