ANTITHROMBIN III ASSAY— 510(k) K780002

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K780002 for ANTITHROMBIN III ASSAY, Substantially Equivalent on 1978-01-31. Applicant: Ortho Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1977-12-30
Decision date: 1978-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ortho Diagnostics, Inc.

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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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