Centrifichem Comb. Serum-Based Calib.
FDA 510(k) K802741 · Union Carbide Corp.
510(k) numberK802741
Submission
- Device name
- Centrifichem Comb. Serum-Based Calib.
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- November 3, 1980
- Decision date
- December 10, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K123372 | Abbott Lipid Multi Constituent CalibratorJIX · Traditional | Abbott Laboratories | 01/14/2013SE |
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| K812536 | Linde Mark IIBYJ · Traditional | 09/23/1981SE |
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| K810596 | Centrifi Chem System 400 AnalyzerJJE · Traditional | 03/17/1981SE |
| K810129 | Centrifichem System 500JJE · Traditional | 02/02/1981SE |
| K803216 | Centrifichem Ast/Sgot Optimized ReagentCIT · Traditional | 01/09/1981SE |
| K802520 | Centrifichem Pipettor Accuracy Calib.JQW · Traditional | 11/12/1980SE |
| K802436 | Centrifichem AlbuminCIX · Traditional | 10/31/1980SE |
Questions and answers
When was Centrifichem Comb. Serum-Based Calib. cleared by the FDA?
Centrifichem Comb. Serum-Based Calib. (K802741) received a 510(k) decision of Substantially Equivalent on December 10, 1980, 37 days after the submission was received.
What is the product code of K802741?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.