Chemistry Analyzer Reagents
FDA 510(k) K792482 · Laboratory Products, Inc.
510(k) numberK792482
Submission
- Device name
- Chemistry Analyzer Reagents
- Applicant
- Laboratory Products, Inc.
Mchenry, IL, US - Received
- November 19, 1979
- Decision date
- January 11, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIX – Bromcresol Green Dye-Binding, Albumin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1035
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251157 | Core MetabolicCIX · Traditional | Truvian Health | 01/09/2026SE |
| K203248 | Albumin BCG2CIX · Traditional | Abbott Ireland Diagnostics Division | 11/23/2021SE |
| K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon…CIX · Traditional | Medicon Hellas S.A | 09/21/2021SE |
| K191316 | VITROS XT Chemistry Products ALB-TP SlidesCIX · Traditional | Ortho-Clinical Diagnostics, Inc. | 06/07/2019SE |
| K170901 | Albumin, Alkaline Phosphatase (Alp)-Amp, Glucose-Hexokinase, BA400CIX · Traditional | Biosystems S.A. | 04/13/2018SE |
| K131488 | Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace…CIX · Traditional | Alfa Wassermann Diagnostics Technologies, LLC | 08/19/2013SE |
| K113374 | Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace…CIX · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 07/13/2012SE |
| K110818 | Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein TestsCIX · Traditional | Polymedco, Inc. | 09/08/2011SE |
| K110830 | Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…CIX · Traditional | Elitechgroup | 06/21/2011SE |
| K101088 | Easyra Albumin, Calcium, Magnesium and Inorganic Phosphorous ReagentCIX · Traditional | Medica Corp. | 04/04/2011SE |
More from Medica Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K832588 | Cin AgarJSJ · Traditional | 09/12/1983SE |
| K803051 | Flame Photometry ReagentsJIX · Traditional | 01/09/1981SE |
| K803013 | CHLORIDE/TCO2 Analyzer ReagentsCHJ · Traditional | 01/02/1981SE |
| K803050 | Spray, Synthetic SmearIFI · Traditional | 12/30/1980SE |
| K800180 | Various Reagents for Blood Cell AnalyzerGIF · Traditional | 03/19/1980SE |
| K792481 | Culture Plates & Tubed MediaJTZ · Traditional | 12/31/1979SE |
| K792483 | Stains, Counterstains & Gen. PurposeICL · Traditional | 12/18/1979SE |
Questions and answers
When was Chemistry Analyzer Reagents cleared by the FDA?
Chemistry Analyzer Reagents (K792482) received a 510(k) decision of Substantially Equivalent on January 11, 1980, 53 days after the submission was received.
What is the product code of K792482?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.