FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONNECTICUT DIAGNOSTICS, LTS. DIRECT
K Number: K792465
·
Decision Dec 18, 1979
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
14
Review Days
15
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Basic Information
- Device Name
- CONNECTICUT DIAGNOSTICS, LTS. DIRECT
- K Number
- K792465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Connecticut Diagnostics, Ltd.
- Date Received
- December 3, 1979
- Decision Date
- December 18, 1979
- Product Code
- CIG
- 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 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 |
| K801897 | GLUCOSE DIAGNOSTIC REAGENT | Oct 10, 1980 | 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 |