FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTRIFICHEM CHOLES. CALIB. STD. SET
K Number: K770126
·
Decision Jan 31, 1977
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
244
Applicant Total
69
Review Days
10
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Basic Information
- Device Name
- CENTRIFICHEM CHOLES. CALIB. STD. SET
- K Number
- K770126
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Union Carbide Corp.
- Date Received
- January 21, 1977
- Decision Date
- January 31, 1977
- Product Code
- JIT
- 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | FDA class 2 | Clinical Chemistry |
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| K Number | Device Name | ||
|---|---|---|---|
| K830337 | MARK III OXYGEN WALKER SYS-LOW PRESS | Mar 17, 1983 | Substantially Equivalent |
| K820836 | MARK III OXYGEN WALKER SYSTEM | Apr 15, 1982 | Substantially Equivalent |
| K820535 | LASER GAS MIXTURES | Mar 31, 1982 | Substantially Equivalent |
| K812536 | LINDE MARK II | Sep 23, 1981 | Substantially Equivalent |
| K810732 | LINDE MARK II OXYGEN RESERV. TYPE OR-4 | Mar 27, 1981 | Substantially Equivalent |
| K810596 | CENTRIFI CHEM SYSTEM 400 ANALYZER | Mar 17, 1981 | Substantially Equivalent |
| K810129 | CENTRIFICHEM SYSTEM 500 | Feb 2, 1981 | Substantially Equivalent |
| K803216 | CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT | Jan 9, 1981 | Substantially Equivalent |
| K802741 | CENTRIFICHEM COMB. SERUM-BASED CALIB. | Dec 10, 1980 | Substantially Equivalent |
| K802520 | CENTRIFICHEM PIPETTOR ACCURACY CALIB. | Nov 12, 1980 | Substantially Equivalent |