Poly-Chem 90 Total Bilirubin
FDA 510(k) K111143 · Polymedco, Inc.
510(k) numberK111143
Submission
- Device name
- Poly-Chem 90 Total Bilirubin
- Applicant
- Polymedco, Inc.
Cortlandt Manor, NY, US - Received
- April 22, 2011
- Decision date
- September 1, 2011
- 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 |
|---|---|---|
| K112408 | Poly-Chem 90 Ise ModuleCEM · Traditional | 11/04/2011SE |
| K110818 | Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein TestsCIX · Traditional | 09/08/2011SE |
| K100550 | Poly-Chem 90 Direct HDL Cholesterol, Poly-Chem 90 Direct LDL Cholesterol, Poly-Chem 90…LBS · Traditional | 09/28/2010SE |
| K090703 | Poly-Chem 90 GlucoseCFR · Traditional | 10/20/2009SE |
| K061944 | Poly-Chem CreatinineJFY · Traditional | 11/03/2006SE |
| K053553 | Nycocard U-Albumin and U-Albumin ControlDCF · Traditional | 03/09/2006SE |
| K041408 | Polymedco Oc Auto Micro 80 Fob TestOOX · Traditional | 10/21/2004SE |
| K041297 | Polymedco Oc Light Fobt TestKHE · Traditional | 08/12/2004SE |
| K033706 | Polymedco Homocysteine Test for the Poly-Chem and Hitachi Chemistry SystemsLPS · Traditional | 02/04/2004SE |
| K023654 | Glyca-Direct FructosamineLCP · Traditional | 05/02/2003SE |
Questions and answers
When was Poly-Chem 90 Total Bilirubin cleared by the FDA?
Poly-Chem 90 Total Bilirubin (K111143) received a 510(k) decision of Substantially Equivalent on September 1, 2011, 132 days after the submission was received.
What is the product code of K111143?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.