Iq Immunochemistry Sistem; Iq TSH Assay
FDA 510(k) K923060 · Becton Dickinson Advanced Diagnostics
510(k) numberK923060
Submission
- Device name
- Iq Immunochemistry Sistem; Iq TSH Assay
- Applicant
- Becton Dickinson Advanced Diagnostics
Sparks, MD, US - Received
- June 25, 1992
- Decision date
- September 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Iq Immunochemistry Sistem; Iq TSH Assay cleared by the FDA?
Iq Immunochemistry Sistem; Iq TSH Assay (K923060) received a 510(k) decision of Substantially Equivalent on September 15, 1992, 82 days after the submission was received.
What is the product code of K923060?
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.