BIODOP(TM)— 510(k) K883334

Substantially Equivalent

Diagnosis Related Systems, Inc.

FDA 510(k) clearance K883334 for BIODOP(TM), Substantially Equivalent on 1988-12-15. Applicant: Diagnosis Related Systems, Inc.. Device class: 2.

Clearance details

Applicant: Diagnosis Related Systems, Inc.
Product code: Code HEK
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 1988-08-09
Decision date: 1988-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

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