RUBINDEX*DIRECT SYSTEM— 510(k) K781638

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K781638 for RUBINDEX*DIRECT SYSTEM, Substantially Equivalent on 1978-12-20. Applicant: Ortho Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code GOK
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1978-09-21
Decision date: 1978-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GOK

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K792635 — ANTIBODY TO RUBELLA VIRUS1980-03-19
K792133 — RUBELISA TEST KIT1980-01-11
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More clearances from Ortho Diagnostics, Inc.

K802404 — ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE1980-10-23
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K800357 — BI-LEVEL ASSAYED CARD. DRUG CONT., I,II1980-04-16
K800310 — ORTHO ANTISERA CONTROL1980-03-05
K791791 — ORTHO ANTIBODY ENHANCEMENT SOLUTION1979-10-11

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