RETICULOCYTE METHOD— 510(k) K954607

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K954607 for RETICULOCYTE METHOD, Substantially Equivalent on 1996-08-30. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1995-10-04
Decision date: 1996-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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