FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHOSPHORUS REAGENT SET
K Number: K823691
·
Decision Jan 7, 1983
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
104
Applicant Total
21
Review Days
30
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Basic Information
- Device Name
- PHOSPHORUS REAGENT SET
- K Number
- K823691
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1580
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Omega Medical Electronics
- Date Received
- December 8, 1982
- Decision Date
- January 7, 1983
- 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 |
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WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
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Other Clearances by Omega Medical Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K821204 | GLUCOSE(ENZYMATIC) REAGENT SET | Jul 22, 1982 | Substantially Equivalent |
| K821206 | SGPT-UV REAGENT SET | Jul 22, 1982 | Substantially Equivalent |
| K821212 | UREA NITROGEN REAGENT SET | Jul 22, 1982 | Substantially Equivalent |
| K821201 | LDH-UV REAGENT SET | Jul 20, 1982 | Substantially Equivalent |
| K821205 | TRIGLYCERIDE REAGENT SET | Jul 20, 1982 | Substantially Equivalent |
| K821208 | SGOT-UV REAGENT SET | Jul 20, 1982 | Substantially Equivalent |
| K821207 | SGPT REAGENT SET | Jul 14, 1982 | Substantially Equivalent |
| K821209 | SGOT REAGENT SET | Jul 14, 1982 | Substantially Equivalent |
| K821199 | CREATININE REAGENT SET | Jul 13, 1982 | Substantially Equivalent |
| K821210 | SERUM TOTAL PROTEIN REAGENT SET | Jul 13, 1982 | Substantially Equivalent |