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510(k) K770209

ECOLYZER CARBOXIMETER by Iadec, Inc. — Product Code GHS

K770209 is an FDA 510(k) premarket notification submitted by Iadec, Inc. for the device "ECOLYZER CARBOXIMETER". The FDA issued a decision of Substantially Equivalent on March 7, 1977. The device falls under product code GHS (Assay, Carboxyhemoglobin), a Class II device regulated under 21 CFR 864.7425.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 7, 1977
Date Received: January 31, 1977
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Assay, Carboxyhemoglobin
Device Class: Class II
Regulation Number: 864.7425
Review Panel: HE
Submission Type