HEMASTIX REAGENT STRIPS— 510(k) K905396
Substantially EquivalentHeraeus Kulzer, Inc.
FDA 510(k) clearance K905396 for HEMASTIX REAGENT STRIPS, Substantially Equivalent on 1991-02-11. Applicant: Heraeus Kulzer, Inc.. Device class: 2.
Clearance details
- Applicant
- Heraeus Kulzer, Inc.
- Product code
- Code JIO
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mishawaka, IN, US
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More clearances from Heraeus Kulzer, Inc.
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