QUALICHECK5+ MODELS S7730, S7740, S7750, S7760— 510(k) K980135
Substantially EquivalentRadiometer America, Inc.
FDA 510(k) clearance K980135 for QUALICHECK5+ MODELS S7730, S7740, S7750, S7760, Substantially Equivalent on 1998-01-28. 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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Recalls naming K980135
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K980135.
Data sourced from openFDA. This site is unofficial and independent of the FDA.