K844105Substantially Equivalent

Fitc Labeled Chlamydiae Monoclonal Antibody

Name: K844105 Fitc Labeled Chlamydiae Monoclonal Antibody
Creator: Bartels Immunodiagnostic Supplies, Inc.
Published: 1984-12-06
License: https://open.fda.gov/license/

Bartels Immunodiagnostic Supplies, Inc., Bellevue WA / Traditional, Substantially Equivalent

FDA source

K844105 is the FDA 510(k) clearance record for FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY, cleared for Bartels Immunodiagnostic Supplies, Inc. on 1984-12-06. FDA records list 35 510(k) clearances for Bartels Immunodiagnostic Supplies, Inc., from 1981-05-05 to 1986-12-31. As of 2026-09-10, FDA records show no recalls naming K844105.

Clearance record

Decision date: 1984-12-06
Received: 1984-10-23 (44 days to decision)
Review panel: Unknown
Applicant: Bartels Immunodiagnostic Supplies, Inc. P.O. Box 3093, Bellevue WA
Third party review: No