Trace Cobas Mira Range
FDA 510(k) K952488 · Trace Scientific , Ltd.
510(k) numberK952488
Submission
- Device name
- Trace Cobas Mira Range
- Applicant
- Trace Scientific , Ltd.
Miami, FL, US - Received
- May 30, 1995
- Decision date
- October 13, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CIX – Bromcresol Green Dye-Binding, Albumin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1035
- Specialty
- Clinical Chemistry
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| 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 |
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| 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 |
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| K932713 | Trace Transferrin ReagentDDQ · Traditional | 09/30/1993SE |
| K923322 | Trace Albumin-Mr ReagentCIX · Traditional | 09/11/1992SE |
| K914731 | Trace Gamma Gt-Ss ReagentJQB · Traditional | 11/19/1991SE |
| K911866 | Trace Total/Direct Bilirubin ReagentCIG · Traditional | 07/17/1991SE |
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Questions and answers
When was Trace Cobas Mira Range cleared by the FDA?
Trace Cobas Mira Range (K952488) received a 510(k) decision of Substantially Equivalent on October 13, 1995, 136 days after the submission was received.
What is the product code of K952488?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.