FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KING DIAGNOSTICS TOTAL BILIRUBIN TEST
K Number: K811881
·
Decision Jul 23, 1981
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
233
Applicant Total
41
Review Days
22
Basic Information
- Device Name
- KING DIAGNOSTICS TOTAL BILIRUBIN TEST
- K Number
- K811881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- KING DIAGNOSTICS, INC.
- Date Received
- July 1, 1981
- Decision Date
- July 23, 1981
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CIG), ordered by most recent decision date.
Atellica® CH Diazo Direct Bilirubin (D_DBil)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica® CH Diazo Total Bilirubin (D_TBil)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Total Bilirubin2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS XT Chemistry Products TBIL-ALKP Slides
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Total Bilirubin
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by KING DIAGNOSTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K933329 | KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT | Oct 22, 1993 | Substantially Equivalent |
| K931834 | KING SODIUM/POTASSIUM STANDARD MODIFIED | Aug 25, 1993 | Substantially Equivalent |
| K931773 | HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) | Aug 16, 1993 | Substantially Equivalent |
| K931326 | KING DIAGNOSTICS CK REAGENT | Jun 15, 1993 | Substantially Equivalent |
| K923129 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT | Nov 2, 1992 | Substantially Equivalent |
| K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT | Oct 13, 1992 | Substantially Equivalent |
| K922921 | KING DIAGNOSTICS CHLORIDE REAGENT | Oct 5, 1992 | Substantially Equivalent |
| K923927 | KING DIAGNOSTICS MAGNESIUM REAGENT | Sep 30, 1992 | Substantially Equivalent |
| K923128 | KING DIAGNOSTICS CHOLESTEROL REAGENT | Sep 9, 1992 | Substantially Equivalent |
| K923091 | KING DIAGNOSTICS GAMMA GT REAGENT | Sep 9, 1992 | Substantially Equivalent |