PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST— 510(k) K883430
Substantially EquivalentDisease Detection International, Inc.
FDA 510(k) clearance K883430 for PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST, Substantially Equivalent on 1989-01-30. Applicant: Disease Detection International, Inc.. Device class: 2.
Clearance details
- Applicant
- Disease Detection International, 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
- Irvine, CA, US
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More clearances from Disease Detection International, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.