PREGNANCY TEST KIT, OVER-THE-COUNTER— 510(k) K780321
Substantially EquivalentIntl. Diagnostic, Inc.
FDA 510(k) clearance K780321 for PREGNANCY TEST KIT, OVER-THE-COUNTER, Substantially Equivalent on 1978-04-04. Applicant: Intl. Diagnostic, Inc.. Device class: 2.
Clearance details
- Applicant
- Intl. Diagnostic, 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
- Mchenry, IL, US
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More clearances from Intl. Diagnostic, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.