Opera System
FDA 510(k) K943376 · Miles, Inc.
510(k) numberK943376
Submission
- Device name
- Opera System
- Applicant
- Miles, Inc.
Tarrytown, NY, US - Received
- July 13, 1994
- Decision date
- September 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJC – Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2150
- Specialty
- Clinical Chemistry
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| K881056 | Amresco Flow Pac Random Access Liquid #4901030JJC · Traditional | American Research Products Co. | 11/15/1988SE |
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| K945655 | Creatinine (Enzymatic UV) Procedure for Technicon Systems (in Vitro Diagnostic Test…CGX · Traditional | 01/05/1995SE |
| K941171 | Technicon H* 3 RTC System (In-Vitro Diagnostic System)GKZ · Traditional | 12/14/1994SE |
| K941156 | Technison Axon SystemKHS · Traditional | 04/26/1994SE |
| K933682 | Direct Amylase (Ec 3.2.1.1) Method for Technicon SystemsJFJ · Traditional | 04/12/1994SE |
| K935287 | Iron -Ii (Fe-Ii) Method/Tech Chem 1(R) 1+TM SystemJIY · Traditional | 01/03/1994SE |
| K933478 | Technicon H*1 Systems, Labfacts Software for U.I.W. Versions 4.11 & 5.11GKZ · Traditional | 11/22/1993SE |
| K933475 | Technicon H* 2 System, Labfacts Software for U.I.W. Versions 4.11 & 5.11GKZ · Traditional | 11/22/1993SE |
Questions and answers
When was Opera System cleared by the FDA?
Opera System (K943376) received a 510(k) decision of Substantially Equivalent on September 14, 1994, 63 days after the submission was received.
What is the product code of K943376?
The FDA product code is JJC – Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2150.