ANTITHROMBIN III RIA— 510(k) K780012

Substantially Equivalent

Ria Diagnostics

FDA 510(k) clearance K780012 for ANTITHROMBIN III RIA, Substantially Equivalent on 1978-01-20. Applicant: Ria Diagnostics. Device class: 2.

Clearance details

Applicant: Ria Diagnostics
Product code: Code DDQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1978-01-03
Decision date: 1978-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DDQ

K972257 — N-ASSAY TIA ANTITHROMBIN III TEST KIT1997-10-20
K935307 — DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA1994-11-22
K932713 — TRACE TRANSFERRIN REAGENT1993-09-30

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