PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT— 510(k) K881125
Substantially EquivalentKallestad Diag, A Div. of Erbamont, Inc.
FDA 510(k) clearance K881125 for PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT, Substantially Equivalent on 1988-03-23. Applicant: Kallestad Diag, A Div. of Erbamont, Inc.. Device class: 1.
Clearance details
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Product code
- Code LIO
- Device class
- Class 1
- Regulation
- 21 CFR 866.2900
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
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