FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRACHEM T-BILI 64971 GILFORD 3500
K Number: K780524
·
Decision May 19, 1978
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
116
Review Days
49
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ULTRACHEM T-BILI 64971 GILFORD 3500
- K Number
- K780524
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Harleco
- Date Received
- March 31, 1978
- Decision Date
- May 19, 1978
- 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 Total Bilirubin (D_TBil)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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
Other Clearances by Harleco
| K Number | Device Name | ||
|---|---|---|---|
| K820233 | ULTRAZYME PLUS GAMMA GT(65055-65056) | Feb 12, 1982 | Substantially Equivalent |
| K813427 | ULTRACHEM GLUC-DH | Dec 31, 1981 | Substantially Equivalent |
| K813042 | ULTRACHEM GLUC-DH SET, ITEM #65048 | Nov 10, 1981 | Substantially Equivalent |
| K813039 | ULTRACHEM E-CHOL, ITEM #65025 | Nov 10, 1981 | Substantially Equivalent |
| K813043 | ULTRACHEM CREA ITEM #64972 | Nov 10, 1981 | Substantially Equivalent |
| K813040 | ULTRACHEM CA, ITEM #64975 | Nov 10, 1981 | Substantially Equivalent |
| K813044 | ULTRACHEM ALB, ITEM #64970 | Nov 10, 1981 | Substantially Equivalent |
| K813041 | ULTRAZYME-GT, ITEM #64959 & 65032 | Nov 10, 1981 | Substantially Equivalent |
| K813038 | ULTRACHEM TP, ITEM #64974 | Nov 10, 1981 | Substantially Equivalent |
| K812593 | ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 | Oct 2, 1981 | Substantially Equivalent |