IL88640 & 88641 CASSETTE-TAPE PROGRAM— 510(k) K801131

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K801131 for IL88640 & 88641 CASSETTE-TAPE PROGRAM, Substantially Equivalent on 1980-05-23. Applicant: Instrumentation Laboratory CO.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code JQP
Advisory panel: Clinical Chemistry
Date received: 1980-05-12
Decision date: 1980-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JQP

product code JQP

Death: 3
Malfunction: 690
Total: 693

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.