Acth Normal Range
FDA 510(k) K842249 · Diagnostic Systems Laboratories, Inc.
510(k) numberK842249
Submission
- Device name
- Acth Normal Range
- Applicant
- Diagnostic Systems Laboratories, Inc.
Walker, MI, US - Received
- June 6, 1984
- Decision date
- August 15, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CKG – Radioimmunoassay, Acth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1025
- Specialty
- Clinical Chemistry
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Questions and answers
When was Acth Normal Range cleared by the FDA?
Acth Normal Range (K842249) received a 510(k) decision of Substantially Equivalent on August 15, 1984, 70 days after the submission was received.
What is the product code of K842249?
The FDA product code is CKG – Radioimmunoassay, Acth, a Class II (moderate risk) device regulated under 21 CFR 862.1025.