ANTISMOOTH MUSCLE ANTIBODY TEST SYS— 510(k) K810983

Name: FDA 510(k) clearance K810983
Creator: U.S. Food and Drug Administration
Published: 1981-05-01

Substantially Equivalent

Immuno-Products Industries

FDA 510(k) clearance K810983 for ANTISMOOTH MUSCLE ANTIBODY TEST SYS, Substantially Equivalent on 1981-05-01. Applicant: Immuno-Products Industries. Device class: 2.

Clearance details

Applicant: Immuno-Products Industries
Product code: Code DBE
Device class: Class 2
Regulation: 21 CFR 866.5120
Advisory panel: Immunology
Date received: 1981-04-13
Decision date: 1981-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K771155 — ANTI-MITOCHONDRIAL1977-08-04
K760156 — TEST, (IVDP) SMOOTHMUSCLE ANTIBODY1976-07-20

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K852231 — ANA/LITE-HEP-2 TEST SYSTEM1985-07-10
K843613 — FLUORESCENT TREPONEMEL ANTIBODY-ABSORB1984-10-31
K831054 — ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB1983-04-27

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