Bilirubin, Total and Direct, Product No, 122-01, 122-02, 122-03, 122-04
FDA 510(k) K991866 · A.P. Total Care, Inc.
510(k) numberK991866
Submission
- Device name
- Bilirubin, Total and Direct, Product No, 122-01, 122-02, 122-03, 122-04
- Applicant
- A.P. Total Care, Inc.
Bridgeport, CT, US - Received
- June 1, 1999
- Decision date
- August 2, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K991246 | Fructosamine, Model FR 106-01LCP · Traditional | 12/16/1999SE |
| K991762 | Alkaline Phophatase (Alp), Product No's 118-01, 118-02CJE · Traditional | 09/02/1999SE |
| K991761 | Magnesium Product No's, 112-01, 112-02JGJ · Traditional | 09/02/1999SE |
| K991664 | LDL Cholesterol, Product No's, 124-01, CH102-01LBS · Traditional | 08/19/1999SE |
| K991665 | HDL Cholesterol, Product No's 124-01, CH102-01LBS · Traditional | 08/10/1999SE |
| K991867 | Inorganic Phosphorus (Ip), Product No's, 112-01, 112-02CEO · Traditional | 08/02/1999SE |
| K991870 | Electrolytes (Na+, K+, Cl-), Product No's 114-01, 114-02, 114-03CGZ · Traditional | 07/30/1999SE |
| K991666 | Tibc, Product No's 123-0, 123-02, FE109-01, FE109-02JMO · Traditional | 06/30/1999SE |
| K991663 | Ast/SgotCIT · Traditional | 06/30/1999SE |
| K991247 | Uric Acid, Model UA112-01KNK · Traditional | 05/25/1999SE |
Questions and answers
When was Bilirubin, Total and Direct, Product No, 122-01, 122-02, 122-03, 122-04 cleared by the FDA?
Bilirubin, Total and Direct, Product No, 122-01, 122-02, 122-03, 122-04 (K991866) received a 510(k) decision of Substantially Equivalent on August 2, 1999, 62 days after the submission was received.
What is the product code of K991866?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.