Distat ANTI-SCL-70 Kit
FDA 510(k) K912291 · Shield Diagnostics, Ltd.
510(k) numberK912291
Submission
- Device name
- Distat ANTI-SCL-70 Kit
- Applicant
- Shield Diagnostics, Ltd.
Dundee, GB - Received
- May 23, 1991
- Decision date
- July 30, 1991
- 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 Distat ANTI-SCL-70 Kit cleared by the FDA?
Distat ANTI-SCL-70 Kit (K912291) received a 510(k) decision of Substantially Equivalent on July 30, 1991, 68 days after the submission was received.
What is the product code of K912291?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.