EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST— 510(k) K970424
Substantially EquivalentExcel Scientific, Inc.
FDA 510(k) clearance K970424 for EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST, Substantially Equivalent on 1997-03-06. Applicant: Excel Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Excel Scientific, Inc.
- 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
- Yorba Linda, CA, US
Recent devices under product code JHI
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- K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
More clearances from Excel Scientific, Inc.
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.