Chemtrak Platinum Comprehensive Liquid Assayed Chemistry and TDM Control Level 1, Model AP11001, Level 2, Model AP22002
FDA 510(k) K980514 · Medical Analysis Systems, Inc.
510(k) numberK980514
Submission
- Device name
- Chemtrak Platinum Comprehensive Liquid Assayed Chemistry and TDM Control Level 1, Model AP11001, Level 2, Model AP22002
- Applicant
- Medical Analysis Systems, Inc.
Camarillo, CA, US - Received
- February 10, 1998
- Decision date
- March 4, 1998
- 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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| 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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Questions and answers
When was Chemtrak Platinum Comprehensive Liquid Assayed Chemistry and TDM Control Level 1, Model AP11001, Level 2, Model AP22002 cleared by the FDA?
Chemtrak Platinum Comprehensive Liquid Assayed Chemistry and TDM Control Level 1, Model AP11001, Level 2, Model AP22002 (K980514) received a 510(k) decision of Substantially Equivalent on March 4, 1998, 22 days after the submission was received.
What is the product code of K980514?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.