FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHNICON RA SYSTEM THYROXINE T4 METHOD
K Number: K894575
·
Decision Oct 4, 1989
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
120
Applicant Total
157
Review Days
75
Basic Information
- Device Name
- TECHNICON RA SYSTEM THYROXINE T4 METHOD
- K Number
- K894575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- TECHNICON INSTRUMENTS CORP.
- Date Received
- July 21, 1989
- Decision Date
- October 4, 1989
- Product Code
- CDX
- 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 |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDX), ordered by most recent decision date.
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TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
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STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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| K Number | Device Name | ||
|---|---|---|---|
| K914888 | TECHNICON CHEM 1(TM) SYST (GEN2 SYST) | Nov 27, 1991 | Substantially Equivalent |
| K914511 | TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL | Nov 27, 1991 | Substantially Equivalent |
| K914025 | TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) | Nov 22, 1991 | Substantially Equivalent |
| K912616 | TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES | Sep 25, 1991 | Substantially Equivalent |
| K912413 | CHEM-LINK DATA BASE MANAGER | Jul 1, 1991 | Substantially Equivalent |
| K903824 | DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY | Sep 27, 1990 | Substantially Equivalent |
| K903305 | TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD | Sep 27, 1990 | Substantially Equivalent |
| K903825 | DRUG OF ABUSE ANALYSIS SYSTEM | Sep 27, 1990 | Substantially Equivalent |
| K903306 | TECHNICON CHEM I SYSTEM MAGNESIUM METHOD | Aug 29, 1990 | Substantially Equivalent |
| K901410 | TECHNICON RA-2000(TM) SYSTEM | Jul 17, 1990 | Substantially Equivalent |