Discrete Photometric Chemistry Analyzer
FDA 510(k) K943493 · Hamilton Co.
510(k) numberK943493
Submission
- Device name
- Discrete Photometric Chemistry Analyzer
- Applicant
- Hamilton Co.
Snellville, GA, US - Received
- July 19, 1994
- Decision date
- January 30, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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Questions and answers
When was Discrete Photometric Chemistry Analyzer cleared by the FDA?
Discrete Photometric Chemistry Analyzer (K943493) received a 510(k) decision of Substantially Equivalent on January 30, 1995, 195 days after the submission was received.
What is the product code of K943493?
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.