PAR-ONE— 510(k) K981391
Substantially EquivalentRemel, Inc.
FDA 510(k) clearance K981391 for PAR-ONE, Substantially Equivalent on 1998-07-14. Applicant: Remel, Inc.. Device class: 1.
Clearance details
- Applicant
- Remel, Inc.
- Product code
- Code LIO
- Device class
- Class 1
- Regulation
- 21 CFR 866.2900
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lenexa, KS, US
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