Ck/Mb Immuno-Isoenzyme Control Serum
FDA 510(k) K840793 · Seragen Diagnostics, Inc.
510(k) numberK840793
Submission
- Device name
- Ck/Mb Immuno-Isoenzyme Control Serum
- Applicant
- Seragen Diagnostics, Inc.
Walker, MI, US - Received
- February 23, 1984
- Decision date
- April 13, 1984
- 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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| K851521 | LD-1(IMMUNO) Separation SetCEX · Traditional | 05/10/1985SE |
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| K844743 | Seratest Ena(Rnp/Sm) DeterminationLLL · Traditional | 02/04/1985SE |
| K842563 | Seratest DNA DeterminationLKJ · Traditional | 10/25/1984SE |
| K841504 | Quick-Count Plus 2GKL · Traditional | 06/11/1984SE |
| K840863 | Seratest RF Latex DeterminationDHR · Traditional | 04/04/1984SE |
Questions and answers
When was Ck/Mb Immuno-Isoenzyme Control Serum cleared by the FDA?
Ck/Mb Immuno-Isoenzyme Control Serum (K840793) received a 510(k) decision of Substantially Equivalent on April 13, 1984, 50 days after the submission was received.
What is the product code of K840793?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.