FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER
K Number: K880949
·
Decision Apr 5, 1988
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
46
Applicant Total
21
Review Days
29
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Basic Information
- Device Name
- SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER
- K Number
- K880949
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Advanced Biomedical Methods, Inc.
- Date Received
- March 7, 1988
- Decision Date
- April 5, 1988
- Product Code
- CJY
- 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 |
|---|---|---|---|
| CJY | Azo Dye, Calcium | FDA class 2 | Clinical Chemistry |
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Other Clearances by Advanced Biomedical Methods, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945353 | CLARIT(TM) | Dec 9, 1994 | Substantially Equivalent |
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| K852784 | ALKALINE PHOSPHATASE | Jul 22, 1985 | Substantially Equivalent |
| K852783 | SGOT/ALT REAGENT | Jul 22, 1985 | Substantially Equivalent |
| K852027 | GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER | May 29, 1985 | Substantially Equivalent |
| K850380 | INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |
| K850379 | DIRECT BILIRUBIN FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |
| K850378 | LDH REAGENT FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |
| K850381 | MAGNESIUM REAGENT FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |
| K844331 | TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER | Jan 3, 1985 | Substantially Equivalent |