Chemistry Control-Low & High TQC TM
FDA 510(k) K770380 · Technicon Instruments Corp.
510(k) numberK770380
Submission
- Device name
- Chemistry Control-Low & High TQC TM
- Applicant
- Technicon Instruments Corp.
Mchenry, IL, US - Received
- February 25, 1977
- Decision date
- April 15, 1977
- 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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| 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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| K912616 | Technicon Immuno 1 TM System Additional AnalytesKLI · Traditional | 09/25/1991SE |
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| K903825 | Drug of Abuse Analysis SystemDIS · Traditional | 09/27/1990SE |
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Questions and answers
When was Chemistry Control-Low & High TQC TM cleared by the FDA?
Chemistry Control-Low & High TQC TM (K770380) received a 510(k) decision of Substantially Equivalent on April 15, 1977, 49 days after the submission was received.
What is the product code of K770380?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.