Hatch Kit
FDA 510(k) K831855 · Radioassay Systems Laboratories, Inc.
510(k) numberK831855
Submission
- Device name
- Hatch Kit
- Applicant
- Radioassay Systems Laboratories, Inc.
Mchenry, IL, US - Received
- June 9, 1983
- Decision date
- July 28, 1983
- 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 Hatch Kit cleared by the FDA?
Hatch Kit (K831855) received a 510(k) decision of Substantially Equivalent on July 28, 1983, 49 days after the submission was received.
What is the product code of K831855?
The FDA product code is CKG – Radioimmunoassay, Acth, a Class II (moderate risk) device regulated under 21 CFR 862.1025.