POLYCHACO INDIRECT HEMAGGLUTINATION— 510(k) K830870

Name: FDA 510(k) clearance K830870
Creator: U.S. Food and Drug Administration
Published: 1983-08-12

Substantially Equivalent

Parasitic Disease Consultants

FDA 510(k) clearance K830870 for POLYCHACO INDIRECT HEMAGGLUTINATION, Substantially Equivalent on 1983-08-12. Applicant: Parasitic Disease Consultants. Device class: 2.

Clearance details

Applicant: Parasitic Disease Consultants
Product code: Code GMM
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1983-03-18
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GMM

view all

K981263 — TOXOGEN1998-08-06
K952818 — ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII1995-11-20
K851976 — HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT1985-10-16
K851977 — HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT1985-10-16
K802452 — TOXOTEST-MT EIKEN KIT1980-12-18

More clearances from Parasitic Disease Consultants

view all

K830869 — POLYCHACO INDIRECT IMMUNOFLUORESCENCE1983-08-11
K831296 — POLYCHACO FIA-ABS TEST FOR SYPHILIS1983-07-26

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