FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEM-LINK DATA BASE MANAGER
K Number: K912413
·
Decision Jul 1, 1991
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
157
Review Days
31
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Basic Information
- Device Name
- CHEM-LINK DATA BASE MANAGER
- K Number
- K912413
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Technicon Instruments Corp.
- Date Received
- May 31, 1991
- Decision Date
- July 1, 1991
- Product Code
- JJQ
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Technicon Instruments Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K914511 | TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL | Nov 27, 1991 | Substantially Equivalent |
| K914888 | TECHNICON CHEM 1(TM) SYST (GEN2 SYST) | 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 |
| K903825 | DRUG OF ABUSE ANALYSIS SYSTEM | Sep 27, 1990 | Substantially Equivalent |
| K903305 | TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD | Sep 27, 1990 | Substantially Equivalent |
| K903824 | DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY | 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 |
| K902243 | TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES | Jul 5, 1990 | Substantially Equivalent |