Serum 11-DESOXYCORTISOL I AS Tracer
FDA 510(k) K791740 · Radioassay Systems Laboratories, Inc.
510(k) numberK791740
Submission
- Device name
- Serum 11-DESOXYCORTISOL I AS Tracer
- Applicant
- Radioassay Systems Laboratories, Inc.
Mchenry, IL, US - Received
- September 10, 1979
- Decision date
- September 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JKB – Radioimmunoassay, Compound S (11-Deoxycortisol)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1185
- Specialty
- Clinical Chemistry
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Questions and answers
When was Serum 11-DESOXYCORTISOL I AS Tracer cleared by the FDA?
Serum 11-DESOXYCORTISOL I AS Tracer (K791740) received a 510(k) decision of Substantially Equivalent on September 27, 1979, 17 days after the submission was received.
What is the product code of K791740?
The FDA product code is JKB – Radioimmunoassay, Compound S (11-Deoxycortisol), a Class I (low risk) device regulated under 21 CFR 862.1185.