Seragan ACTH125 I-Ria Kit
FDA 510(k) K822115 · Seragen Diagnostics, Inc.
510(k) numberK822115
Submission
- Device name
- Seragan ACTH125 I-Ria Kit
- Applicant
- Seragen Diagnostics, Inc.
Mchenry, IL, US - Received
- July 19, 1982
- Decision date
- October 18, 1982
- 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 Seragan ACTH125 I-Ria Kit cleared by the FDA?
Seragan ACTH125 I-Ria Kit (K822115) received a 510(k) decision of Substantially Equivalent on October 18, 1982, 91 days after the submission was received.
What is the product code of K822115?
The FDA product code is CKG – Radioimmunoassay, Acth, a Class II (moderate risk) device regulated under 21 CFR 862.1025.