FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOCHEK POCKETLAB
K Number: K951457
·
Decision Feb 22, 1996
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
8
Review Days
330
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Basic Information
- Device Name
- GLUCOCHEK POCKETLAB
- K Number
- K951457
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Clinical Diagnostics, Inc.
- Date Received
- March 29, 1995
- Decision Date
- February 22, 1996
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | 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 |
| K940215 | GLUCOCHEK | Jan 17, 1995 | Substantially Equivalent |
| K854903 | GORDON DIAGNOSTIC SYSTEM MODEL I | Jun 2, 1986 | 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 |