Acth Standard Matrix
FDA 510(k) K842099 · Diagnostic Systems Laboratories, Inc.
510(k) numberK842099
Submission
- Device name
- Acth Standard Matrix
- Applicant
- Diagnostic Systems Laboratories, Inc.
Walker, MI, US - Received
- May 25, 1984
- Decision date
- August 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Acth Standard Matrix cleared by the FDA?
Acth Standard Matrix (K842099) received a 510(k) decision of Substantially Equivalent on August 17, 1984, 84 days after the submission was received.
What is the product code of K842099?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.