Quanta Lite Mitochondria M2 Elisa
FDA 510(k) K933180 · Inova Diagnostics, Inc.
510(k) numberK933180
Submission
- Device name
- Quanta Lite Mitochondria M2 Elisa
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- June 30, 1993
- Decision date
- August 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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Questions and answers
When was Quanta Lite Mitochondria M2 Elisa cleared by the FDA?
Quanta Lite Mitochondria M2 Elisa (K933180) received a 510(k) decision of Substantially Equivalent on August 5, 1993, 36 days after the submission was received.
What is the product code of K933180?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.