FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALKALINE PHOSPHATASE REAGENT SET
K Number: K843332
·
Decision Sep 14, 1984
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
122
Applicant Total
15
Review Days
18
Basic Information
- Device Name
- ALKALINE PHOSPHATASE REAGENT SET
- K Number
- K843332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- STERLING BIOCHEMICAL, INC.
- Date Received
- August 27, 1984
- Decision Date
- September 14, 1984
- Product Code
- CJE
- 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 |
|---|---|---|---|
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | FDA class 2 | 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 |
| 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 |
| K834045 | URIC ACID REAGENT SET | Jan 30, 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 |