FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOSE DIAGNOSTIC REAGENT
K Number: K801897
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
14
Review Days
63
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Basic Information
- Device Name
- GLUCOSE DIAGNOSTIC REAGENT
- K Number
- K801897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Connecticut Diagnostics, Ltd.
- Date Received
- August 8, 1980
- Decision Date
- October 10, 1980
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Connecticut Diagnostics, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K905617 | VISI-STAPH | Mar 29, 1991 | Substantially Equivalent |
| K822500 | CDL LYSING REAGENT | Sep 17, 1982 | Substantially Equivalent |
| K822501 | CDL ISOTONIC DILUENT | Sep 17, 1982 | Substantially Equivalent |
| K822504 | CDL AUTO-LYSING REAGENT | Sep 17, 1982 | Substantially Equivalent |
| K811222 | INORGANIC PHOSPHORUS REAGENTS | May 21, 1981 | Substantially Equivalent |
| K801898 | URIC ACID DIAGNOSTIC REAGENT | Oct 10, 1980 | Substantially Equivalent |
| K792465 | CONNECTICUT DIAGNOSTICS, LTS. DIRECT | Dec 18, 1979 | Substantially Equivalent |
| K792338 | DONNECT. DIAG. TOTAL BILIRUBIN REAGENTS | Dec 6, 1979 | Substantially Equivalent |
| K792362 | BLOOD UREA NITROGEN REAGENT | Dec 6, 1979 | Substantially Equivalent |
| K792339 | CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN | Dec 6, 1979 | Substantially Equivalent |