Multichem IA Plus
FDA 510(k) K162530 · Techno-Path Manufacturing
510(k) numberK162530
Submission
- Device name
- Multichem IA Plus
- Applicant
- Techno-Path Manufacturing
Co. Tipperary, IE - Received
- September 9, 2016
- Decision date
- March 31, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 03/10/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | Bio-Rad Laboratories | 01/10/2017SE |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | Maine Standards Company, LLC | 04/30/2015SE |
| 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 |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
| K133676 | Abx Pentra Micro Alb Control L/HJJY · Abbreviated | Horiba Abx SAS | 07/11/2014SE |
More from Horiba Abx SAS
| 510(k) | Device | Decision |
|---|---|---|
| K242492 | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG)…QCH · Traditional | 12/30/2025SE |
| K132751 | Multichem S Plus / S Plus (Assayed)JJY · Abbreviated | 10/22/2013SE |
| K131993 | Multichem UJJY · Abbreviated | 10/15/2013SE |
| K131992 | Multichem PJJY · Abbreviated | 09/25/2013SE |
| K132174 | Multichem WBTDIF · Abbreviated | 09/20/2013SE |
| K132091 | Multichem Ia and Ia PlusJJY · Abbreviated | 09/20/2013SE |
Questions and answers
When was Multichem IA Plus cleared by the FDA?
Multichem IA Plus (K162530) received a 510(k) decision of Substantially Equivalent on March 31, 2017, 203 days after the submission was received.
What is the product code of K162530?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.