MILES URINE AMYLASE METHOD— 510(k) K923105
Substantially EquivalentHeraeus Kulzer, Inc.
FDA 510(k) clearance K923105 for MILES URINE AMYLASE METHOD, Substantially Equivalent on 1992-09-28. Applicant: Heraeus Kulzer, Inc.. Device class: 2.
Clearance details
- Applicant
- Heraeus Kulzer, Inc.
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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