Collection Kit Chlamydia Trachomatis
FDA 510(k) K832079 · Syva Co.
510(k) numberK832079
Submission
- Device name
- Collection Kit Chlamydia Trachomatis
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- June 28, 1983
- Decision date
- September 29, 1983
- 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 Collection Kit Chlamydia Trachomatis cleared by the FDA?
Collection Kit Chlamydia Trachomatis (K832079) received a 510(k) decision of Substantially Equivalent on September 29, 1983, 93 days after the submission was received.
What is the product code of K832079?
The FDA product code is LIO – Device, Specimen Collection, a Class I (low risk) device regulated under 21 CFR 866.2900.