DIGOXIN RIA (PEG) KIT— 510(k) K781335

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K781335 for DIGOXIN RIA (PEG) KIT, Substantially Equivalent on 1978-08-31. Applicant: Ortho Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code DOG
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1978-08-02
Decision date: 1978-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DOG

K810477 — DCA DIGOX-SYN RIA TEST1981-03-11
K803045 — IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.1980-12-22
K760709 — EMIT DIGOKIN ASSAY1976-10-21
K760416 — DATA-TOPE SYSTEM DIGOXIN RIA1976-08-23

More clearances from Ortho Diagnostics, Inc.

K802404 — ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE1980-10-23
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

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