Document Enzyme Linearity Test Sets
FDA 510(k) K861506 · Casco Standards
510(k) numberK861506
Submission
- Device name
- Document Enzyme Linearity Test Sets
- Applicant
- Casco Standards
Yarmouth, ME, US - Received
- April 23, 1986
- Decision date
- June 13, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJT – Enzyme Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Document Enzyme Linearity Test Sets cleared by the FDA?
Document Enzyme Linearity Test Sets (K861506) received a 510(k) decision of Substantially Equivalent on June 13, 1986, 51 days after the submission was received.
What is the product code of K861506?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.