FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHOSPHORUS
K Number: K895999
·
Decision Jan 11, 1990
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
104
Applicant Total
73
Review Days
90
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Basic Information
- Device Name
- PHOSPHORUS
- K Number
- K895999
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1580
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- American Monitor Corp.
- Date Received
- October 13, 1989
- Decision Date
- January 11, 1990
- Product Code
- CEO
- 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 |
|---|---|---|---|
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEO), ordered by most recent decision date.
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PICCOLO PHOSPHORUS TEST SYSTEM
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WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by American Monitor Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K896000 | ASPARTATE AMINOTRANFERASE (AST) | Jan 11, 1990 | Substantially Equivalent |
| K896001 | ALANINE AMINOTRANSFERASE (ALT) | Nov 13, 1989 | Substantially Equivalent |
| K895423 | ACCESS CHEMISTRY ANALYZER | Oct 4, 1989 | Substantially Equivalent |
| K893137 | EXCEL (TM) CHEMISTRY ANALYZER | Aug 10, 1989 | Substantially Equivalent |
| K892331 | ENZYMATIC UREA NITROGEN REAGENT SET | Jun 20, 1989 | Substantially Equivalent |
| K893479 | CHOLESTEROL REAGENT SET | Jun 19, 1989 | Substantially Equivalent |
| K892002 | NEOCHROME(R) III GLUCOSE | Jun 12, 1989 | Substantially Equivalent |
| K890312 | GAMMA-GLUTAMYLTRANSFERASE | Mar 24, 1989 | Substantially Equivalent |
| K890034 | PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) | Feb 3, 1989 | Substantially Equivalent |
| K883504 | DURAZYME(R) CPK | Sep 13, 1988 | Substantially Equivalent |