ANA LATEX SLIDE TEST— 510(k) K800605

Substantially Equivalent

Biologics Intl., Inc.

FDA 510(k) clearance K800605 for ANA LATEX SLIDE TEST, Substantially Equivalent on 1980-04-02. Applicant: Biologics Intl., Inc.. Device class: 2.

Clearance details

Applicant: Biologics Intl., Inc.
Product code: Code DHC
Device class: Class 2
Regulation: 21 CFR 866.5820
Advisory panel: Immunology
Date received: 1980-03-17
Decision date: 1980-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Biologics Intl., Inc.

K882229 — AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS1988-08-16
K823353 — CARCINO-CEK1982-12-14
K812060 — BI-ASO SLIDE TEST1981-08-13
K811374 — BI-CRP LATEX TEST1981-06-12
K811375 — BI-RA SLIDE TEST1981-06-12

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