QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)— 510(k) K961354
Substantially EquivalentRadiometer America, Inc.
FDA 510(k) clearance K961354 for QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660), Substantially Equivalent on 1996-06-14. Applicant: Radiometer America, Inc.. Device class: 1.
Clearance details
- Applicant
- Radiometer America, Inc.
- Product code
- Code JJS
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westlake, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.