AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR— 510(k) K981978
Substantially EquivalentPointe Scientific, Inc.,
FDA 510(k) clearance K981978 for AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR, Substantially Equivalent on 1998-07-22. Applicant: Pointe Scientific, Inc.,. Device class: 1.
Clearance details
- Applicant
- Pointe Scientific, Inc.,
- Product code
- Code MRR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincoln Park, MI, US
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More clearances from Pointe Scientific, Inc.,
view allData sourced from openFDA. This site is unofficial and independent of the FDA.