Id-Zone LD Isoenzyme Control
FDA 510(k) K822984 · Beckman Instruments, Inc.
510(k) numberK822984
Submission
- Device name
- Id-Zone LD Isoenzyme Control
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- October 12, 1982
- Decision date
- November 10, 1982
- 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 Id-Zone LD Isoenzyme Control cleared by the FDA?
Id-Zone LD Isoenzyme Control (K822984) received a 510(k) decision of Substantially Equivalent on November 10, 1982, 29 days after the submission was received.
What is the product code of K822984?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.