Ck/Ld Isoenzymes Controls(Human)
FDA 510(k) K851520 · Seragen Diagnostics, Inc.
510(k) numberK851520
Submission
- Device name
- Ck/Ld Isoenzymes Controls(Human)
- Applicant
- Seragen Diagnostics, Inc.
Indianapolis, IN, US - Received
- April 15, 1985
- Decision date
- June 25, 1985
- 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 Ck/Ld Isoenzymes Controls(Human) cleared by the FDA?
Ck/Ld Isoenzymes Controls(Human) (K851520) received a 510(k) decision of Substantially Equivalent on June 25, 1985, 71 days after the submission was received.
What is the product code of K851520?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.