IMMUNOZYME TOXOPLASMA ANTIBODY— 510(k) K780352

Substantially Equivalent

Millipore Corp.

FDA 510(k) clearance K780352 for IMMUNOZYME TOXOPLASMA ANTIBODY, Substantially Equivalent on 1978-06-28. Applicant: Millipore Corp.. Device class: 2.

Clearance details

Applicant: Millipore Corp.
Product code: Code GLZ
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1978-03-03
Decision date: 1978-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GLZ

K924882 — TOXOPLASMA IGM IFA TEST SYSTEM1993-03-23
K880007 — TOXO IGM TEST1988-03-17
K850591 — FIAX TOXO-M ANTIBODIES TEST KIT1985-04-30
K844287 — ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII1985-01-07
K842664 — ANTI-TOXOPLASMA GONDII KIT1984-08-28

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