FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENZYMATIC UREA NITROGEN REAGENT SET REVI
K Number: K800719
·
Decision May 8, 1980
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
116
Applicant Total
23
Review Days
38
Basic Information
- Device Name
- ENZYMATIC UREA NITROGEN REAGENT SET REVI
- K Number
- K800719
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- MACOMB CHEMICAL CO.
- Date Received
- March 31, 1980
- Decision Date
- May 8, 1980
- 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 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 |
| K800720 | MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO | Apr 21, 1980 | Substantially Equivalent |
| K792533 | CREATINE PHOSPHOKINASE (CPK) REAGENT SET | Jan 11, 1980 | Substantially Equivalent |
| K792532 | GLUCOSE (HEXOKINASE) 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 |