Polymedco Spotchem Ez Chemistry Analyzer
FDA 510(k) K040332 · Arkray, Inc.
510(k) numberK040332
Submission
- Device name
- Polymedco Spotchem Ez Chemistry Analyzer
- Applicant
- Arkray, Inc.
Cortlandt Manor, NY, US - Received
- February 10, 2004
- Decision date
- June 16, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJF – Analyzer, Chemistry, Micro, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2170
- Specialty
- Clinical Chemistry
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| K053401 | Spotchem II Chemistry Basic 1 and Chemistry Basic 2 TestsCIC · Traditional | 03/24/2006SE |
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Questions and answers
When was Polymedco Spotchem Ez Chemistry Analyzer cleared by the FDA?
Polymedco Spotchem Ez Chemistry Analyzer (K040332) received a 510(k) decision of Substantially Equivalent on June 16, 2004, 127 days after the submission was received.
What is the product code of K040332?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.