SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP— 510(k) K893548
Substantially EquivalentHeraeus Kulzer, Inc.
FDA 510(k) clearance K893548 for SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP, Substantially Equivalent on 1989-08-03. Applicant: Heraeus Kulzer, Inc.. Device class: 1.
Clearance details
- Applicant
- Heraeus Kulzer, Inc.
- Product code
- Code LBS
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
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