FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K Number: K941171
·
Decision Dec 14, 1994
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
11
Review Days
275
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Basic Information
- Device Name
- TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
- K Number
- K941171
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Miles, Inc.
- Date Received
- March 14, 1994
- Decision Date
- December 14, 1994
- Product Code
- GKZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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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 |
| K943376 | OPERA SYSTEM | Sep 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 |