ANA TEST KIT— 510(k) K811022

Substantially Equivalent

Immuno-Diagnostic Products, Inc.

FDA 510(k) clearance K811022 for ANA TEST KIT, Substantially Equivalent on 1981-04-23. Applicant: Immuno-Diagnostic Products, Inc.. Device class: 2.

Clearance details

Applicant: Immuno-Diagnostic Products, Inc.
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1981-04-15
Decision date: 1981-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: MD, US

Download summary PDF View on FDA.gov ↗

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More clearances from Immuno-Diagnostic Products, Inc.

K854207 — EBV(EPSTEIN-BARR VIRUS) TEST KIT1986-04-24
K811021 — HERPES1981-11-05
K811562 — TOXOPLASMOSIS TEST KIT1981-07-16
K801959 — FTA-ABS TEST1980-10-23
K801963 — CMV TEST KIT1980-10-23

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