CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY— 510(k) K872426

Name: FDA 510(k) clearance K872426
Creator: U.S. Food and Drug Administration
Published: 1987-07-23

Substantially Equivalent

Cytotech, Inc.

FDA 510(k) clearance K872426 for CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY, Substantially Equivalent on 1987-07-23. Applicant: Cytotech, Inc.. Device class: 2.

Clearance details

Applicant: Cytotech, Inc.
Product code: Code DBA
Device class: Class 2
Regulation: 21 CFR 866.5250
Advisory panel: Immunology
Date received: 1987-06-22
Decision date: 1987-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cytotech, Inc.

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K882829 — CIRCULATING IMMUNE COMPLEXES CONTROLS1988-08-04
K874379 — CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY1987-11-25
K873249 — ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS1987-09-22
K871801 — CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT1987-06-09
K864315 — CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY1987-02-02

Recalls naming K872426

K-number listed on FDA's recall record

Z-1308-2023 — MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or aboveClass II·Ongoing·Quidel Corporation·20230201

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K872426.

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