FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CENTRIFICHEM SYS 400 ANALYZER
K Number: K771813
·
Decision Oct 25, 1977
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
29
Applicant Total
8
Review Days
28
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Basic Information
- Device Name
- CENTRIFICHEM SYS 400 ANALYZER
- K Number
- K771813
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2140
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Clinical Diagnostics, Inc.
- Date Received
- September 27, 1977
- Decision Date
- October 25, 1977
- Product Code
- JJG
- 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 |
|---|---|---|---|
| JJG | Analyzer, Chemistry, Centrifugal, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Clinical Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971653 | GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM | Jan 2, 1998 | Substantially Equivalent |
| K951457 | GLUCOCHEK POCKETLAB | Feb 22, 1996 | Substantially Equivalent |
| K940215 | GLUCOCHEK | Jan 17, 1995 | Substantially Equivalent |
| K854903 | GORDON DIAGNOSTIC SYSTEM MODEL I | Jun 2, 1986 | Substantially Equivalent |
| K771118 | CENTRIA SEPARATION COLUMNS TYPE A | Jul 11, 1977 | Substantially Equivalent |
| K771117 | CENTRIA CORTISOL RIA | Jun 23, 1977 | Substantially Equivalent |
| K761272 | CENTRIA T4 RIA | Mar 16, 1977 | Substantially Equivalent |