Dade Indirect Imt System with TCO2 Electrode
FDA 510(k) K970330 · Dade Intl., Inc.
510(k) numberK970330
Submission
- Device name
- Dade Indirect Imt System with TCO2 Electrode
- Applicant
- Dade Intl., Inc.
Newark, DE, US - Received
- January 28, 1997
- Decision date
- April 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEM – Electrode, Ion Specific, Potassium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1600
- Specialty
- Clinical Chemistry
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| K112412 | AU5800(R) Chemistry AnalyzerCEM · Traditional | Beckman Coulter, Inc. | 12/23/2011SE |
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| K972782 | Dade Stratus Ck-Mb Fluorometric Enzyme ImmunoassayJHX · Traditional | 08/15/1997SE |
| K972287 | Dade Tru-Liquid Bilirubin ControlJJX · Traditional | 07/07/1997SE |
| K964660 | Paramax Cholesterol ReagentCHH · Traditional | 06/04/1997SE |
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Questions and answers
When was Dade Indirect Imt System with TCO2 Electrode cleared by the FDA?
Dade Indirect Imt System with TCO2 Electrode (K970330) received a 510(k) decision of Substantially Equivalent on April 14, 1997, 76 days after the submission was received.
What is the product code of K970330?
The FDA product code is CEM – Electrode, Ion Specific, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.