SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS— 510(k) K870752
Substantially EquivalentMiles Laboratories, Inc.
FDA 510(k) clearance K870752 for SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS, Substantially Equivalent on 1987-04-14. Applicant: Miles Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Miles Laboratories, Inc.
- Product code
- Code CFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1440
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
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