ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE— 510(k) K802404

Name: FDA 510(k) clearance K802404
Creator: U.S. Food and Drug Administration
Published: 1980-10-23

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K802404 for ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE, Substantially Equivalent on 1980-10-23. Applicant: Ortho Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code DCF
Device class: Class 2
Regulation: 21 CFR 866.5040
Advisory panel: Immunology
Date received: 1980-10-06
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DCF

view all

K153560 — Optilite Low Level Albumin Kit2016-08-25
K143118 — Human Microalbumin kit for use on SPAPLUS2015-05-26
K142346 — Urine/CSF Albumin, Urine/CSF Albumin Calibrator2014-10-15
K121045 — HUMAN ALBUMIN CSF KIT2013-06-19
K113072 — TINA-QUANT ALBUMIN GEN.22012-05-14

More clearances from Ortho Diagnostics, Inc.

view all

K801507 — ANTIGEN CONTROL CELLS1980-08-20
K800357 — BI-LEVEL ASSAYED CARD. DRUG CONT., I,II1980-04-16
K800310 — ORTHO ANTISERA CONTROL1980-03-05
K791791 — ORTHO ANTIBODY ENHANCEMENT SOLUTION1979-10-11
K791301 — ORTHO TSH RIA KIT1979-09-24

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