DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000— 510(k) K010973
Substantially EquivalentHypoguard USA, Inc.
FDA 510(k) clearance K010973 for DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000, Substantially Equivalent on 2001-09-11. Applicant: Hypoguard USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Hypoguard USA, Inc.
- Product code
- Code JIL
- Device class
- Class 2
- Regulation
- 21 CFR 862.1340
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edina, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.