FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPERA SYSTEM
K Number: K943376
·
Decision Sep 14, 1994
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
31
Applicant Total
11
Review Days
63
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Basic Information
- Device Name
- OPERA SYSTEM
- K Number
- K943376
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Miles, Inc.
- Date Received
- July 13, 1994
- Decision Date
- September 14, 1994
- Product Code
- JJC
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Miles, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950292 | FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM | May 2, 1995 | Substantially Equivalent |
| K950353 | TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | Apr 20, 1995 | Substantially Equivalent |
| K950186 | CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | Mar 13, 1995 | Substantially Equivalent |
| K945655 | CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM) | Jan 5, 1995 | Substantially Equivalent |
| K941171 | TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) | Dec 14, 1994 | Substantially Equivalent |
| K941156 | TECHNISON AXON SYSTEM | Apr 26, 1994 | Substantially Equivalent |
| K933682 | DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS | Apr 12, 1994 | Substantially Equivalent |
| K935287 | IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM | Jan 3, 1994 | Substantially Equivalent |
| K933475 | TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 | Nov 22, 1993 | Substantially Equivalent |
| K933478 | TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 | Nov 22, 1993 | Substantially Equivalent |