I-L Test, Direct Bilirubin Set
FDA 510(k) K850748 · Allied Instrumentation Laboratory
510(k) numberK850748
Submission
- Device name
- I-L Test, Direct Bilirubin Set
- Applicant
- Allied Instrumentation Laboratory
Lexington, MA, US - Received
- February 25, 1985
- Decision date
- April 3, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K861901 | MULTI-4 Co-Oximeter ControlJJY · Traditional | 06/17/1986SE |
| K860365 | Phenobarbital Test SystemDLZ · Traditional | 03/17/1986SE |
| K860286 | Il Test PhenytoinDIP · Traditional | 03/05/1986SE |
| K853858 | Il Test Theophylline AssayKLS · Traditional | 10/15/1985SE |
| K852676 | Il System 1304 & 1306, Ph/Blood Gas AnalyzersCHL · Traditional | 07/22/1985SE |
| K851933 | Clinical Chemistry Analytical SystemJJF · Traditional | 06/10/1985SE |
Questions and answers
When was I-L Test, Direct Bilirubin Set cleared by the FDA?
I-L Test, Direct Bilirubin Set (K850748) received a 510(k) decision of Substantially Equivalent on April 3, 1985, 37 days after the submission was received.
What is the product code of K850748?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.