CARDS Q.S. HCG SERUM/URINE; CONCISE PERFORMANCE PLUS HCG-COMBO— 510(k) K973858
Substantially EquivalentQuidel Corp.
FDA 510(k) clearance K973858 for CARDS Q.S. HCG SERUM/URINE; CONCISE PERFORMANCE PLUS HCG-COMBO, Substantially Equivalent on 1997-11-26. Applicant: Quidel Corp.. Device class: 2.
Clearance details
- Device name as filed
- CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO
- Applicant
- Quidel Corp.
- Product code
- Code JHI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Quidel Corp.
view allAdverse events under product code JHI
product code JHI- Malfunction
- 1,055
- Total
- 1,055
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.