Pathodx(Tm) Chlamydia Direct Specimen (PDCY1)
FDA 510(k) K893905 · Diagnostic Products Corp.
510(k) numberK893905
Submission
- Device name
- Pathodx(Tm) Chlamydia Direct Specimen (PDCY1)
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- May 30, 1989
- Decision date
- August 3, 1989
- 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 Pathodx(Tm) Chlamydia Direct Specimen (PDCY1) cleared by the FDA?
Pathodx(Tm) Chlamydia Direct Specimen (PDCY1) (K893905) received a 510(k) decision of Substantially Equivalent on August 3, 1989, 65 days after the submission was received.
What is the product code of K893905?
The FDA product code is LIO – Device, Specimen Collection, a Class I (low risk) device regulated under 21 CFR 866.2900.