FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYSTEM 5 - SEMI-AUTOMATED CLIN. ANALY
K Number: K760749
·
Decision Dec 29, 1976
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
31
Applicant Total
16
Review Days
90
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Basic Information
- Device Name
- SYSTEM 5 - SEMI-AUTOMATED CLIN. ANALY
- K Number
- K760749
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Gilford Instrument Laboratories, Inc.
- Date Received
- September 30, 1976
- Decision Date
- December 29, 1976
- Product Code
- JJC
- 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 |
|---|---|---|---|
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Gilford Instrument Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823233 | SBA 300 CLINICAL CHEMISTRY ANALYZER | Nov 29, 1982 | Substantially Equivalent |
| K821583 | AMES/GILFORD OPTIMATE CLIN. CHEM & THER | Jun 24, 1982 | Substantially Equivalent |
| K802609 | CHEMISTRY ANALYZER IMPACT 400 | Nov 26, 1980 | Substantially Equivalent |
| K801889 | MODEL 203S CLINICAL CHEMISTRY ANALYZER | Sep 26, 1980 | Substantially Equivalent |
| K800085 | SYSTEM 203 CHEMISTRY ANALYZER | Feb 13, 1980 | Substantially Equivalent |
| K792361 | SYSTEM 103 CHEMISTRY ANALYZER | Dec 27, 1979 | Substantially Equivalent |
| K792087 | MICROFLAME PHOTOMETER | Nov 13, 1979 | Substantially Equivalent |
| K791968 | EIA (ELISA) READER | Oct 17, 1979 | Substantially Equivalent |
| K790072 | ANALYZER, IMPACT 200 | Feb 22, 1979 | Substantially Equivalent |
| K790073 | ANALYZER, IMPACT 100 | Feb 22, 1979 | Substantially Equivalent |