Pathodx Respiratory Virus Panel Model PKRP1
FDA 510(k) K983336 · Diagnostic Products Corp.
510(k) numberK983336
Submission
- Device name
- Pathodx Respiratory Virus Panel Model PKRP1
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- September 23, 1998
- Decision date
- March 18, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKT – Respiratory Syncytial Virus, Antigen, Antibody, Ifa
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3480
- Specialty
- Microbiology
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Questions and answers
When was Pathodx Respiratory Virus Panel Model PKRP1 cleared by the FDA?
Pathodx Respiratory Virus Panel Model PKRP1 (K983336) received a 510(k) decision of Substantially Equivalent on March 18, 1999, 176 days after the submission was received.
What is the product code of K983336?
The FDA product code is LKT – Respiratory Syncytial Virus, Antigen, Antibody, Ifa, a Class I (low risk) device regulated under 21 CFR 866.3480.