FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLINICAL CHEMISTRY ANALYTICAL SYSTEM
K Number: K851933
·
Decision Jun 10, 1985
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
7
Review Days
39
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Basic Information
- Device Name
- CLINICAL CHEMISTRY ANALYTICAL SYSTEM
- K Number
- K851933
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Allied Instrumentation Laboratory
- Date Received
- May 2, 1985
- Decision Date
- June 10, 1985
- Product Code
- JJF
- 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 |
|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Allied Instrumentation Laboratory
| K Number | Device Name | ||
|---|---|---|---|
| K861901 | MULTI-4 CO-OXIMETER CONTROL | Jun 17, 1986 | Substantially Equivalent |
| K860365 | PHENOBARBITAL TEST SYSTEM | Mar 17, 1986 | Substantially Equivalent |
| K860286 | IL TEST PHENYTOIN | Mar 5, 1986 | Substantially Equivalent |
| K853858 | IL TEST THEOPHYLLINE ASSAY | Oct 15, 1985 | Substantially Equivalent |
| K852676 | IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS | Jul 22, 1985 | Substantially Equivalent |
| K850748 | I-L TEST, DIRECT BILIRUBIN SET | Apr 3, 1985 | Substantially Equivalent |