FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URIC ACID REAGENT SET
K Number: K834045
·
Decision Jan 30, 1984
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
117
Applicant Total
15
Review Days
68
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Basic Information
- Device Name
- URIC ACID REAGENT SET
- K Number
- K834045
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sterling Biochemical, Inc.
- Date Received
- November 23, 1983
- Decision Date
- January 30, 1984
- Product Code
- KNK
- 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 |
|---|---|---|---|
| KNK | Acid, Uric, Uricase (Colorimetric) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Sterling Biochemical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K844998 | GLUCOSE(HEXOKINASE) REAGENT SET | Jan 18, 1985 | Substantially Equivalent |
| K844251 | ALT/GPT REAGENT SET | Jan 8, 1985 | Substantially Equivalent |
| K843332 | ALKALINE PHOSPHATASE REAGENT SET | Sep 14, 1984 | Substantially Equivalent |
| K842521 | AST/GOT REAGENT SET UV RATE | Aug 12, 1984 | Substantially Equivalent |
| K840064 | UREA NITROGEN REAGENT SET | Jun 14, 1984 | Substantially Equivalent |
| K834084 | HYDROXYBUTYRATE DEHYDROGENASE REAGENT | Feb 4, 1984 | Substantially Equivalent |
| K833864 | AMYLASE REAGENT SET-MODIFIED CARAWAY | Jan 13, 1984 | Substantially Equivalent |
| K833062 | SERUM CHOLINESTERASE REAGENT SET | Nov 25, 1983 | Substantially Equivalent |
| K831874 | LIPASE REAGENT SET | Aug 12, 1983 | Substantially Equivalent |
| K831415 | LACTIC DEHYDROGENASE REAGENT SET | Jun 16, 1983 | Substantially Equivalent |