Excel (TM) Chemistry Analyzer
FDA 510(k) K893137 · American Monitor Corp.
510(k) numberK893137
Submission
- Device name
- Excel (TM) Chemistry Analyzer
- Applicant
- American Monitor Corp.
Indianapolis, IN, US - Received
- April 25, 1989
- Decision date
- August 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896000 | Aspartate Aminotranferase (Ast)CIT · Traditional | 01/11/1990SE |
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| K896001 | Alanine Aminotransferase (Alt)CKA · Traditional | 11/13/1989SE |
| K895423 | Access Chemistry AnalyzerJJE · Traditional | 10/04/1989SE |
| K892331 | Enzymatic Urea Nitrogen Reagent SetCDQ · Traditional | 06/20/1989SE |
| K893479 | Cholesterol Reagent SetCHH · Traditional | 06/19/1989SE |
| K892002 | Neochrome(R) III GlucoseCGA · Traditional | 06/12/1989SE |
| K890312 | Gamma-GlutamyltransferaseJQB · Traditional | 03/24/1989SE |
| K890034 | Photometric Method, Iron (Non-Heme) (75JIY)JIY · Traditional | 02/03/1989SE |
| K883504 | Durazyme(R) CPKCGS · Traditional | 09/13/1988SE |
Questions and answers
When was Excel (TM) Chemistry Analyzer cleared by the FDA?
Excel (TM) Chemistry Analyzer (K893137) received a 510(k) decision of Substantially Equivalent on August 10, 1989, 107 days after the submission was received.
What is the product code of K893137?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.