Level II Control Serum
FDA 510(k) K821558 · Irvine Scientific
510(k) numberK821558
Submission
- Device name
- Level II Control Serum
- Applicant
- Irvine Scientific
Mchenry, IL, US - Received
- May 25, 1982
- Decision date
- July 2, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJX – Single (Specified) Analyte 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 Level II Control Serum cleared by the FDA?
Level II Control Serum (K821558) received a 510(k) decision of Substantially Equivalent on July 2, 1982, 38 days after the submission was received.
What is the product code of K821558?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.