EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST— 510(k) K971286
Substantially EquivalentExcel Scientific, Inc.
FDA 510(k) clearance K971286 for EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST, Substantially Equivalent on 1997-05-08. Applicant: Excel Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Excel Scientific, Inc.
- Product code
- Code LCX
- 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
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More clearances from Excel Scientific, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.