ANTI-HUMAN IGG SERUM— 510(k) K791281

Substantially Equivalent

Diagnostica, Inc.

FDA 510(k) clearance K791281 for ANTI-HUMAN IGG SERUM, Substantially Equivalent on 1979-11-27. Applicant: Diagnostica, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostica, Inc.
Product code: Code DEW
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1979-07-10
Decision date: 1979-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Diagnostica, Inc.

K002756 — EASE-A-CULT2001-02-23
K823348 — H. INFLUENZA B ANTISERA FOR CIE1982-12-28
K812434 — DIAGNOSTIC KITS & KIT COMPONENTS1981-09-23
K800398 — PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT1980-03-12
K791283 — ANTI-HUMAN LAMBDA SERUM1979-11-27

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