Rheumelisa II Histone Antibody Test Kit
FDA 510(k) K932679 · Biowhittaker Molecular Applications, Inc.
510(k) numberK932679
Submission
- Device name
- Rheumelisa II Histone Antibody Test Kit
- Applicant
- Biowhittaker Molecular Applications, Inc.
Walkersville, MD, US - Received
- June 2, 1993
- Decision date
- August 23, 1993
- 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 Rheumelisa II Histone Antibody Test Kit cleared by the FDA?
Rheumelisa II Histone Antibody Test Kit (K932679) received a 510(k) decision of Substantially Equivalent on August 23, 1993, 82 days after the submission was received.
What is the product code of K932679?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.