Triage Total Controls 5, Triage Total Calibration Verification 5
FDA 510(k) K072892 · Biosite Incorporated
510(k) numberK072892
Submission
- Device name
- Triage Total Controls 5, Triage Total Calibration Verification 5
- Applicant
- Biosite Incorporated
San Diego, CA, US - Received
- October 10, 2007
- Decision date
- December 7, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
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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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| K062530 | Triage Protein C TestGGP · Traditional | 01/29/2007SE |
| K060788 | Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414DIF · Traditional | 07/10/2006SE |
| K060791 | Triage Tox Drug Screen, Model 94400DJR · Traditional | 06/22/2006SE |
| K052789 | Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200NBC · Traditional | 01/23/2006SE |
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Questions and answers
When was Triage Total Controls 5, Triage Total Calibration Verification 5 cleared by the FDA?
Triage Total Controls 5, Triage Total Calibration Verification 5 (K072892) received a 510(k) decision of Substantially Equivalent on December 7, 2007, 58 days after the submission was received.
What is the product code of K072892?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.