FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BL BILIRUBINOMETER
K Number: K790608
·
Decision Jun 15, 1979
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
16
Review Days
78
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
- BL BILIRUBINOMETER
- K Number
- K790608
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Advanced Instruments, Inc.
- Date Received
- March 29, 1979
- Decision Date
- June 15, 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 |
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 Advanced Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K152776 | Glocyte Automated Cell Counter System | May 27, 2016 | Substantially Equivalent |
| K120631 | PATIENT MONITOR | May 25, 2012 | Substantially Equivalent |
| K112465 | VITAL SIGNS MONITOR | Sep 14, 2011 | Substantially Equivalent |
| K965036 | THE ADVANCED OSMOMETER (3900) | Feb 20, 1997 | Substantially Equivalent |
| K962056 | ADVANCED MICRO-OSMOMETER MODEL 3300 | Jul 11, 1996 | Substantially Equivalent |
| K930526 | INTERMITTENT COMPRESSION SYSTEM MODEL 5000 | Nov 18, 1993 | Substantially Equivalent |
| K925970 | MODEL 3D3 OSMOMETER | Jul 9, 1993 | Substantially Equivalent |
| K911092 | OSMOMETER MODEL 2400 | May 22, 1991 | Substantially Equivalent |
| K873642 | OSMOMETER MODEL 110 | Oct 20, 1987 | Substantially Equivalent |
| K863516 | ELECTRONIC METAL LOCATOR MODEL MD-1 | Sep 30, 1986 | Substantially Equivalent |