OPERA SYSTEM— 510(k) K943376
Substantially EquivalentMiles, Inc.
FDA 510(k) clearance K943376 for OPERA SYSTEM, Substantially Equivalent on 1994-09-14. Applicant: Miles, Inc.. Device class: 1.
Clearance details
- Applicant
- Miles, Inc.
- Product code
- Code JJC
- Device class
- Class 1
- Regulation
- 21 CFR 862.2150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code JJC
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- K945655 — CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM)
- K941171 — TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
Data sourced from openFDA. This site is unofficial and independent of the FDA.