LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)— 510(k) K862255
Substantially EquivalentSterling Diagnostics, Inc.
FDA 510(k) clearance K862255 for LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE), Substantially Equivalent on 1986-07-29. Applicant: Sterling Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sterling Diagnostics, 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
- Sterling Heights, MI, US
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More clearances from Sterling Diagnostics, Inc.
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