MICROALBUSTIX REAGENT STRIPS— 510(k) K982219
Substantially EquivalentBayer Corp.
FDA 510(k) clearance K982219 for MICROALBUSTIX REAGENT STRIPS, Substantially Equivalent on 1998-08-12. Applicant: Bayer Corp.. Device class: 1.
Clearance details
- Applicant
- Bayer Corp.
- Product code
- Code JIR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1645
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.