FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
N-ASSAY L D-BIL
K Number: K981276
·
Decision May 1, 1998
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
29
Review Days
23
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
- N-ASSAY L D-BIL
- K Number
- K981276
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Crestat Diagnostics, Inc.
- Date Received
- April 8, 1998
- Decision Date
- May 1, 1998
- 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 Crestat Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980883 | N-ASSAY GLU-UL | Sep 3, 1998 | Substantially Equivalent |
| K981289 | N-ASSAY L T-BIL | Apr 27, 1998 | Substantially Equivalent |
| K980902 | N-ASSAY L AST/GOT | Mar 26, 1998 | Substantially Equivalent |
| K980900 | N-ASSAY CPK-L | Mar 26, 1998 | Substantially Equivalent |
| K971985 | N-ASSAY TIA PLASMINOGEN TEST KIT | Oct 20, 1997 | Substantially Equivalent |
| K972257 | N-ASSAY TIA ANTITHROMBIN III TEST KIT | Oct 20, 1997 | Substantially Equivalent |
| K964296 | N-ASSAY TIA APO B TEST KIT | Aug 1, 1997 | Substantially Equivalent |
| K964294 | N-ASSAY TIA APO A1/B MULTI CALIBRATOR | Aug 1, 1997 | Substantially Equivalent |
| K964292 | N-ASSAY TIA APO A1 TEST KIT | Aug 1, 1997 | Substantially Equivalent |
| K965100 | N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT | Jul 14, 1997 | Substantially Equivalent |