ANTI-HUMAN SERUM— 510(k) K791282

Substantially Equivalent

Diagnostica, Inc.

FDA 510(k) clearance K791282 for ANTI-HUMAN SERUM, Substantially Equivalent on 1979-10-17. Applicant: Diagnostica, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostica, Inc.
Product code: Code DGQ
Device class: Class 1
Regulation: 21 CFR 866.5700
Advisory panel: Immunology
Date received: 1979-07-10
Decision date: 1979-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K800398 — PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT1980-03-12
K791281 — ANTI-HUMAN IGG SERUM1979-11-27

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