FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENZYMATIC UREA NITROGEN REAGENT SET
K Number: K860109
·
Decision Feb 6, 1986
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
116
Applicant Total
21
Review Days
24
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Basic Information
- Device Name
- ENZYMATIC UREA NITROGEN REAGENT SET
- K Number
- K860109
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Technostics Intl.
- Date Received
- January 13, 1986
- Decision Date
- February 6, 1986
- Product Code
- CDQ
- 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 |
|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
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Other Clearances by Technostics Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K855188 | CPK (UV) REAGENT KIT | Mar 5, 1986 | Substantially Equivalent |
| K860111 | URIC ACID REAGENT SET | Feb 19, 1986 | Substantially Equivalent |
| K855190 | MAGNESIUM REAGENT SET | Feb 18, 1986 | Substantially Equivalent |
| K860110 | GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET | Feb 11, 1986 | Substantially Equivalent |
| K860112 | TOTAL LIPIDS REAGENT SET | Jan 24, 1986 | Substantially Equivalent |
| K855185 | GLUCOSE REAGENT SET | Jan 22, 1986 | Substantially Equivalent |
| K855157 | LACTIC DEHYDROGENASE (VV) REAGENT SET | Jan 21, 1986 | Substantially Equivalent |
| K855194 | GLUCOSE OXIDASE REAGENT SET | Jan 14, 1986 | Substantially Equivalent |
| K855153 | GLUCOSE (UV HEXOKIASE) REAGENT SET | Jan 14, 1986 | Substantially Equivalent |
| K855193 | CREATININE REAGENT SET | Jan 14, 1986 | Substantially Equivalent |