BERICHROM(R) PLASMINOGEN— 510(k) K884766

Name: FDA 510(k) clearance K884766
Creator: U.S. Food and Drug Administration
Published: 1989-01-04

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K884766 for BERICHROM(R) PLASMINOGEN, Substantially Equivalent on 1989-01-04. Applicant: Behring Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code DDX
Device class: Class 1
Regulation: 21 CFR 866.5715
Advisory panel: Immunology
Date received: 1988-11-14
Decision date: 1989-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DDX

view all

K941346 — PLASMINOGEN RID TEST KIT1994-09-09
K864212 — IL TEST 97573-15, PLASMINOGEN ASSAY1986-12-04
K854572 — COATEST PLASMINOGEN1986-02-26
K850410 — GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY1985-05-08
K832591 — DIACROM *PLG1983-11-21

More clearances from Behring Diagnostics, Inc.

view all

K973832 — OPUS HLH CONTROLS1997-10-27
K972929 — N ANTISERUM TO HUMAN ALBUMIN1997-10-20
K972840 — N ANTISERUM TO HUMAN TRANSFERRIN1997-10-17
K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM1997-09-12
K972316 — OPUS D-DIMER1997-09-09

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