FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS
K Number: K771102
·
Decision Nov 22, 1977
Classifications
1
FEI Numbers
66
Registration Numbers
67
Same Product Code
72
Applicant Total
26
Review Days
155
Basic Information
- Device Name
- UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS
- K Number
- K771102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- THE DOW CHEMICAL CO.
- Date Received
- June 20, 1977
- Decision Date
- November 22, 1977
- Product Code
- LFR
- 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 |
|---|---|---|---|
| LFR | Glucose Dehydrogenase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by THE DOW CHEMICAL CO.
| K Number | Device Name | ||
|---|---|---|---|
| K823474 | ENZYMATIC GLUCOSE DETERMINATION | Dec 30, 1982 | Substantially Equivalent |
| K822154 | UREA NITROGEN (ENZYMATIC) DETERMINATION | Aug 5, 1982 | Substantially Equivalent |
| K821536 | DOWFLOW ALT-UV DETERMINATION | Jun 14, 1982 | Substantially Equivalent |
| K821315 | DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM | May 24, 1982 | Substantially Equivalent |
| K820675 | BILIRUBIN(TOTAL) DETERMINATION CTMS | Apr 1, 1982 | Substantially Equivalent |
| K820714 | DOW BILIRUBIN(DIRECT) DETERMINATION | Apr 1, 1982 | Substantially Equivalent |
| K812777 | DIRECT IRON REAGENT SET | Oct 19, 1981 | Substantially Equivalent |
| K811806 | QUICK-CHEM COLORIMETER | Jul 15, 1981 | Substantially Equivalent |
| K810861 | CREATINE KINASE MB ISOENZYME IMMUNO UV | Apr 14, 1981 | Substantially Equivalent |
| K810727 | AST-UV (PLP-ACTIVATED) DETERMINATION | Mar 31, 1981 | Substantially Equivalent |