K865019Substantially Equivalent

Aft(r) Hep Performance Evaluation Program

Name: K865019 Aft(r) Hep Performance Evaluation Program
Creator: Behring Diagnostics, Inc.
Published: 1987-02-10
License: https://open.fda.gov/license/

Behring Diagnostics, Inc., La Jolla CA / Traditional, Substantially Equivalent

FDA source

K865019 is the FDA 510(k) clearance record for AFT(R) HEP PERFORMANCE EVALUATION PROGRAM, cleared for Behring Diagnostics, Inc. on 1987-02-10. FDA records list 145 510(k) clearances for Behring Diagnostics, Inc., from 1976-12-30 to 1997-10-27. As of 2026-09-10, FDA records show no recalls naming K865019.

Clearance record

Decision date: 1987-02-10
Received: 1986-12-23 (49 days to decision)
Review panel: Unknown
Applicant: Behring Diagnostics, Inc. 10933 No Torrey Pines Rd., La Jolla CA
Third party review: No