Anti-Nuclear Antibody (Ana) Test Kit W/Rat Liver
FDA 510(k) K944192 · Light Diagnostics
510(k) numberK944192
Submission
- Device name
- Anti-Nuclear Antibody (Ana) Test Kit W/Rat Liver
- Applicant
- Light Diagnostics
Temecula, CA, US - Received
- August 29, 1994
- Decision date
- March 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
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| K944191 | Anti-Nuclear Antibody(Ana) Test Kit W/Mouse LiverDBL · Traditional | Light Diagnostics | 03/06/1995SE |
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Questions and answers
When was Anti-Nuclear Antibody (Ana) Test Kit W/Rat Liver cleared by the FDA?
Anti-Nuclear Antibody (Ana) Test Kit W/Rat Liver (K944192) received a 510(k) decision of Substantially Equivalent on March 6, 1995, 189 days after the submission was received.
What is the product code of K944192?
The FDA product code is DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5660.