N-Assay L D-Bil
FDA 510(k) K981276 · Crestat Diagnostics, Inc.
510(k) numberK981276
Submission
- Device name
- N-Assay L D-Bil
- Applicant
- Crestat Diagnostics, Inc.
Seattle, WA, US - Received
- April 8, 1998
- Decision date
- May 1, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CIG – Diazo Colorimetry, Bilirubin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1110
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/27/2026SE |
| K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 06/12/2023SE |
| K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/20/2023SE |
| K223324 | Total Bilirubin2CIG · Traditional | Abbott Ireland Diagnostics Division | 12/29/2022SE |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP SlidesCIG · Traditional | Ortho-Clinical Diagnostics, Inc. | 04/26/2019SE |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…CIG · Traditional | Elitechgroup | 07/11/2017SE |
| K150510 | Total BilirubinCIG · Traditional | Abbott Laboratories | 04/02/2015SE |
| K131544 | Cobas C Bilirubin Total GEN.3CIG · Traditional | Roche Diagnostics | 07/17/2013SE |
| K131217 | S Test Reagent Cartridge Total BilirubinCIG · Traditional | Hitachi Chemical Diagnostics, Inc. | 06/07/2013SE |
| K123802 | Easyra Tbil Reagent, Easyra Dbii Reagent, Easyra CK ReagentCIG · Traditional | Medica Corp. | 03/01/2013SE |
More from Medica Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K980883 | N-Assay Glu-UlCFR · Traditional | 09/03/1998SE |
| K981289 | N-Assay L T-BilCIG · Traditional | 04/27/1998SE |
| K980902 | N-Assay L Ast/GotCIT · Traditional | 03/26/1998SE |
| K980900 | N-Assay Cpk-LCGS · Traditional | 03/26/1998SE |
| K972257 | N-Assay Tia Antithrombin III Test KitDDQ · Traditional | 10/20/1997SE |
| K971985 | N-Assay Tia Plasminogen Test KitGGP · Traditional | 10/20/1997SE |
| K964296 | N-Assay Tia Apo B Test KitDER · Traditional | 08/01/1997SE |
| K964294 | N-Assay Tia Apo A1/B Multi CalibratorDER · Traditional | 08/01/1997SE |
| K964292 | N-Assay Tia Apo A1 Test KitDER · Traditional | 08/01/1997SE |
| K965100 | N-Assay Tia ALPHA-1-ANTITRYPSIN Test KitDEM · Traditional | 07/14/1997SE |
Questions and answers
When was N-Assay L D-Bil cleared by the FDA?
N-Assay L D-Bil (K981276) received a 510(k) decision of Substantially Equivalent on May 1, 1998, 23 days after the submission was received.
What is the product code of K981276?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.