Reagents Used-Quan. Measure of Serum
FDA 510(k) K802154 · Panmed, Inc.
510(k) numberK802154
Submission
- Device name
- Reagents Used-Quan. Measure of Serum
- Applicant
- Panmed, Inc.
Mchenry, IL, US - Received
- September 8, 1980
- Decision date
- October 10, 1980
- 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 |
|---|---|---|
| K852767 | Erythocyte CreatineJLA · Traditional | 11/13/1986SE |
| K820642 | Sickle-CheckGHM · Traditional | 04/14/1982SE |
| K802164 | 8-HYDROXYQUINOLINE, Cresolphthalein Com.CIC · Traditional | 10/10/1980SE |
| K802163 | Chloride Color & Chloride Sample DiluentCHJ · Traditional | 10/10/1980SE |
| K802162 | CO2 Color Reagent & CO2 Sample DiluentKMS · Traditional | 10/10/1980SE |
| K802161 | Biuret Reagent & Total Protein Blank SolCEK · Traditional | 10/10/1980SE |
| K802160 | Bun Color Reagent & Bun Acid UsedCDW · Traditional | 10/10/1980SE |
| K802159 | Ammonium Molybdate Inorganic PhosphorusCEO · Traditional | 10/10/1980SE |
| K802158 | Postassium Buffer Sol. & Wash SolutionCEM · Traditional | 10/10/1980SE |
| K802157 | BCG Reagent Serum Albumin W/TechniconCIX · Traditional | 10/10/1980SE |
Questions and answers
When was Reagents Used-Quan. Measure of Serum cleared by the FDA?
Reagents Used-Quan. Measure of Serum (K802154) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 32 days after the submission was received.
What is the product code of K802154?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.