Seratest DNA Determination
FDA 510(k) K842563 · Seragen Diagnostics, Inc.
510(k) numberK842563
Submission
- Device name
- Seratest DNA Determination
- Applicant
- Seragen Diagnostics, Inc.
Indianapolis, IN, US - Received
- July 2, 1984
- Decision date
- October 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKJ – Antinuclear Antibody, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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Questions and answers
When was Seratest DNA Determination cleared by the FDA?
Seratest DNA Determination (K842563) received a 510(k) decision of Substantially Equivalent on October 25, 1984, 115 days after the submission was received.
What is the product code of K842563?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.