Ilab 600 Clinical Chemistry System
FDA 510(k) K980757 · Instrumentation Laboratory CO
510(k) numberK980757
Submission
- Device name
- Ilab 600 Clinical Chemistry System
- Applicant
- Instrumentation Laboratory CO
Lexington, MA, US - Received
- February 27, 1998
- Decision date
- April 21, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
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Questions and answers
When was Ilab 600 Clinical Chemistry System cleared by the FDA?
Ilab 600 Clinical Chemistry System (K980757) received a 510(k) decision of Substantially Equivalent on April 21, 1998, 53 days after the submission was received.
What is the product code of K980757?
The FDA product code is CGZ – Electrode, Ion-Specific, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.