FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOSE (HEXOKINASE) REAGENT SET
K Number: K792532
·
Decision Jan 11, 1980
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
144
Applicant Total
23
Review Days
35
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Basic Information
- Device Name
- GLUCOSE (HEXOKINASE) REAGENT SET
- K Number
- K792532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Macomb Chemical Co.
- Date Received
- December 7, 1979
- Decision Date
- January 11, 1980
- Product Code
- CFR
- 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 |
|---|---|---|---|
| CFR | Hexokinase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Macomb Chemical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K830095 | RAPID CHEM ANALYZER II | Jan 28, 1983 | Substantially Equivalent |
| K823720 | SPECTROPHOTOMETER | Jan 7, 1983 | Substantially Equivalent |
| K810958 | GLYCOHEMOGLOBIN | Sep 16, 1981 | Substantially Equivalent |
| K801086 | P-NITROPHENYL PHOSPHATE | May 28, 1980 | Substantially Equivalent |
| K800719 | ENZYMATIC UREA NITROGEN REAGENT SET REVI | May 8, 1980 | Substantially Equivalent |
| K800720 | MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO | Apr 21, 1980 | Substantially Equivalent |
| K792533 | CREATINE PHOSPHOKINASE (CPK) REAGENT SET | Jan 11, 1980 | Substantially Equivalent |
| K791669 | GLUCOSE OXIDASE REAGENT SET | Sep 24, 1979 | Substantially Equivalent |
| K791511 | ENZYMATIC REAGENT SET, 4X250 ML. | Sep 4, 1979 | Substantially Equivalent |
| K791119 | MACOMB NORMAL CONTROL SERUM | Jul 30, 1979 | Substantially Equivalent |