FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GORDON DIAGNOSTIC SYSTEM MODEL I
K Number: K854903
·
Decision Jun 2, 1986
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
10
Applicant Total
8
Review Days
175
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Basic Information
- Device Name
- GORDON DIAGNOSTIC SYSTEM MODEL I
- K Number
- K854903
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Clinical Diagnostics, Inc.
- Date Received
- December 9, 1985
- Decision Date
- June 2, 1986
- Product Code
- LQD
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| LQD | Recorder, Attention Task Performance | FDA unclassified | Unknown |
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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 |
| K771813 | CENTRIFICHEM SYS 400 ANALYZER | Oct 25, 1977 | 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 |