Modification Microtrak Direct Specimen Test
FDA 510(k) K843935 · Syva Co.
510(k) numberK843935
Submission
- Device name
- Modification Microtrak Direct Specimen Test
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- October 5, 1984
- Decision date
- October 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIO – Device, Specimen Collection
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
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Questions and answers
When was Modification Microtrak Direct Specimen Test cleared by the FDA?
Modification Microtrak Direct Specimen Test (K843935) received a 510(k) decision of Substantially Equivalent on October 23, 1984, 18 days after the submission was received.
What is the product code of K843935?
The FDA product code is LIO – Device, Specimen Collection, a Class I (low risk) device regulated under 21 CFR 866.2900.