Iron-Pc-Sl Assay Model # 151-10, 151-26
FDA 510(k) K020816 · Diagnostic Chemicals , Ltd.
510(k) numberK020816
Submission
- Device name
- Iron-Pc-Sl Assay Model # 151-10, 151-26
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E., CA - Received
- March 13, 2002
- Decision date
- May 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIY – Photometric Method, Iron (Non-Heme)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1410
- Specialty
- Clinical Chemistry
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Questions and answers
When was Iron-Pc-Sl Assay Model # 151-10, 151-26 cleared by the FDA?
Iron-Pc-Sl Assay Model # 151-10, 151-26 (K020816) received a 510(k) decision of Substantially Equivalent on May 14, 2002, 62 days after the submission was received.
What is the product code of K020816?
The FDA product code is JIY – Photometric Method, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.