Encore SCL-70
FDA 510(k) K920150 · Clark Laboratories, Inc.
510(k) numberK920150
Submission
- Device name
- Encore SCL-70
- Applicant
- Clark Laboratories, Inc.
Blairstown, NJ, US - Received
- January 13, 1992
- Decision date
- March 18, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Encore SCL-70 cleared by the FDA?
Encore SCL-70 (K920150) received a 510(k) decision of Substantially Equivalent on March 18, 1992, 65 days after the submission was received.
What is the product code of K920150?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.