ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER— 510(k) K923806
Substantially EquivalentNova Biomedical Corp.
FDA 510(k) clearance K923806 for ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER, Substantially Equivalent on 1992-09-29. Applicant: Nova Biomedical Corp.. Device class: 2.
Clearance details
- Applicant
- Nova Biomedical Corp.
- Product code
- Code JGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1665
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, US
Recent devices under product code JGS
view allMore clearances from Nova Biomedical Corp.
view all- K100602 — NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
- K101633 — NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
- K091547 — NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
- K070960 — NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
- K070255 — NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
Adverse events under product code JGS
product code JGS- Malfunction
- 535
- Total
- 535
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.