MODEL 4900 OFF-LINE PREPARATION SYSTEM— 510(k) K801271
Substantially EquivalentPm America, Inc.
FDA 510(k) clearance K801271 for MODEL 4900 OFF-LINE PREPARATION SYSTEM, Substantially Equivalent on 1980-06-09. Applicant: Pm America, Inc.. Device class: 1.
Clearance details
- Applicant
- Pm America, Inc.
- Product code
- Code JQW
- Device class
- Class 1
- Regulation
- 21 CFR 862.2750
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JQW
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