MIDSTREAM ONESTEP PREGNANCY HOME TEST— 510(k) K963341
Substantially EquivalentSyntron Bioresearch, Inc.
FDA 510(k) clearance K963341 for MIDSTREAM ONESTEP PREGNANCY HOME TEST, Substantially Equivalent on 1996-12-02. Applicant: Syntron Bioresearch, Inc.. Device class: 2.
Clearance details
- Applicant
- Syntron Bioresearch, 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
- Carlsbad, CA, US
Recent devices under product code LCX
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More clearances from Syntron Bioresearch, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.