FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOSE
K Number: K850930
·
Decision Jun 10, 1985
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
11
Applicant Total
11
Review Days
95
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Basic Information
- Device Name
- GLUCOSE
- K Number
- K850930
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dilab, Inc.
- Date Received
- March 7, 1985
- Decision Date
- June 10, 1985
- Product Code
- CGE
- 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 |
|---|---|---|---|
| CGE | Orthotoluidine, Glucose | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
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SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.
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6% ORTHO LOLIUDINE REAGENT IN GLACID ACI
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Other Clearances by Dilab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862530 | RAPID AS LATEX | Apr 21, 1987 | Substantially Equivalent |
| K850931 | ALBUMIN | Jun 26, 1985 | Substantially Equivalent |
| K850938 | CHOLESTEROL | Jun 25, 1985 | Substantially Equivalent |
| K850936 | TOTAL PROTEINS | Jun 25, 1985 | Substantially Equivalent |
| K850932 | CREATININE | Jun 25, 1985 | Substantially Equivalent |
| K850933 | URIC ACID | Jun 25, 1985 | Substantially Equivalent |
| K850934 | PHOSPHORUS | Jun 25, 1985 | Substantially Equivalent |
| K850935 | CHLORIDE | Jun 10, 1985 | Substantially Equivalent |
| K850937 | UREA | Jun 10, 1985 | Substantially Equivalent |
| K850929 | CALCIUM | Jun 10, 1985 | Substantially Equivalent |