Nova 13 Analyzer
FDA 510(k) K912561 · Nova Biomedical Corp.
510(k) numberK912561
Submission
- Device name
- Nova 13 Analyzer
- Applicant
- Nova Biomedical Corp.
Walham, MA, US - Received
- June 11, 1991
- Decision date
- September 11, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
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Questions and answers
When was Nova 13 Analyzer cleared by the FDA?
Nova 13 Analyzer (K912561) received a 510(k) decision of Substantially Equivalent on September 11, 1991, 92 days after the submission was received.
What is the product code of K912561?
The FDA product code is CGZ – Electrode, Ion-Specific, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.