Direct Bilirubin for Demand Analyzer
FDA 510(k) K850379 · Advanced Biomedical Methods, Inc.
510(k) numberK850379
Submission
- Device name
- Direct Bilirubin for Demand Analyzer
- Applicant
- Advanced Biomedical Methods, Inc.
Niles, IL, US - Received
- January 31, 1985
- Decision date
- March 1, 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 |
|---|---|---|
| K945353 | Clarit(Tm)JKA · Traditional | 12/09/1994SE |
| K880949 | Single Reagent Calcium for Demand AnalyzerCJY · Traditional | 04/05/1988SE |
| K864866 | Resubmission of the Kleerzit ReagentJKA · Traditional | 03/16/1987SE |
| K852784 | Alkaline PhosphataseCJE · Traditional | 07/22/1985SE |
| K852783 | Sgot/Alt ReagentCIT · Traditional | 07/22/1985SE |
| K852027 | GGTP Reagent/Serum Iron/Salicylate Demand AnalyzerDKJ · Traditional | 05/29/1985SE |
| K850381 | Magnesium Reagent for Demand AnalyzerJGJ · Traditional | 03/01/1985SE |
| K850380 | Inorganic Phosphorous for Demand AnalyzerCEO · Traditional | 03/01/1985SE |
| K850378 | LDH Reagent for Demand AnalyzerCFJ · Traditional | 03/01/1985SE |
| K844332 | Creatinine Reagent for Demand AnalyzerCGX · Traditional | 01/03/1985SE |
Questions and answers
When was Direct Bilirubin for Demand Analyzer cleared by the FDA?
Direct Bilirubin for Demand Analyzer (K850379) received a 510(k) decision of Substantially Equivalent on March 1, 1985, 29 days after the submission was received.
What is the product code of K850379?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.