FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHNICON RA-1000 SYS, ANALYTES III
K Number: K821514
·
Decision May 10, 1982
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
157
Review Days
—
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Basic Information
- Device Name
- TECHNICON RA-1000 SYS, ANALYTES III
- K Number
- K821514
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Technicon Instruments Corp.
- Date Received
- May 10, 1982
- Decision Date
- May 10, 1982
- Product Code
- JEJ
- Advisory Committee
- Ear, Nose, Throat
- 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 |
|---|---|---|---|
| JEJ | Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JEJ), ordered by most recent decision date.
View allOther Clearances by Technicon Instruments Corp.
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| K912413 | CHEM-LINK DATA BASE MANAGER | Jul 1, 1991 | Substantially Equivalent |
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| 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 |