Coxsackie A2 CF Antigen, A4, A10 & A16
FDA 510(k) K853279 · Hillcrest Biologicals
510(k) numberK853279
Submission
- Device name
- Coxsackie A2 CF Antigen, A4, A10 & A16
- Applicant
- Hillcrest Biologicals
Cypress, CA, US - Received
- August 5, 1985
- Decision date
- November 7, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNO – Antisera, Cf, Coxsackievirus A 1-24, B 1-6
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3145
- Specialty
- Microbiology
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Questions and answers
When was Coxsackie A2 CF Antigen, A4, A10 & A16 cleared by the FDA?
Coxsackie A2 CF Antigen, A4, A10 & A16 (K853279) received a 510(k) decision of Substantially Equivalent on November 7, 1985, 94 days after the submission was received.
What is the product code of K853279?
The FDA product code is GNO – Antisera, Cf, Coxsackievirus A 1-24, B 1-6, a Class I (low risk) device regulated under 21 CFR 866.3145.