MULTI-4 Co-Oximeter Control
FDA 510(k) K861901 · Allied Instrumentation Laboratory
510(k) numberK861901
Submission
- Device name
- MULTI-4 Co-Oximeter Control
- Applicant
- Allied Instrumentation Laboratory
Lexington, MA, US - Received
- May 16, 1986
- Decision date
- June 17, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
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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 |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K860365 | Phenobarbital Test SystemDLZ · Traditional | 03/17/1986SE |
| K860286 | Il Test PhenytoinDIP · Traditional | 03/05/1986SE |
| K853858 | Il Test Theophylline AssayKLS · Traditional | 10/15/1985SE |
| K852676 | Il System 1304 & 1306, Ph/Blood Gas AnalyzersCHL · Traditional | 07/22/1985SE |
| K851933 | Clinical Chemistry Analytical SystemJJF · Traditional | 06/10/1985SE |
| K850748 | I-L Test, Direct Bilirubin SetCIG · Traditional | 04/03/1985SE |
Questions and answers
When was MULTI-4 Co-Oximeter Control cleared by the FDA?
MULTI-4 Co-Oximeter Control (K861901) received a 510(k) decision of Substantially Equivalent on June 17, 1986, 32 days after the submission was received.
What is the product code of K861901?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.