TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE— 510(k) K863841
Substantially EquivalentHybritech, Inc.
FDA 510(k) clearance K863841 for TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE, Substantially Equivalent on 1986-12-22. Applicant: Hybritech, Inc.. Device class: 2.
Clearance details
- Applicant
- Hybritech, 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
- San Diego, CA, US
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More clearances from Hybritech, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.