FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CREATININE REAGENT SET
K Number: K821199
·
Decision Jul 13, 1982
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
158
Applicant Total
21
Review Days
77
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Basic Information
- Device Name
- CREATININE REAGENT SET
- K Number
- K821199
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Omega Medical Electronics
- Date Received
- April 27, 1982
- Decision Date
- July 13, 1982
- Product Code
- CGX
- 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | FDA class 2 | Clinical Chemistry |
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Other Clearances by Omega Medical Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K823691 | PHOSPHORUS REAGENT SET | Jan 7, 1983 | Substantially Equivalent |
| 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 |
| K821210 | SERUM TOTAL PROTEIN REAGENT SET | Jul 13, 1982 | Substantially Equivalent |