IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1— 510(k) K872678

Name: FDA 510(k) clearance K872678
Creator: U.S. Food and Drug Administration
Published: 1987-08-07

Substantially Equivalent

I.A.F. Production, Inc.

FDA 510(k) clearance K872678 for IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1, Substantially Equivalent on 1987-08-07. Applicant: I.A.F. Production, Inc.. Device class: 1.

Clearance details

Applicant: I.A.F. Production, Inc.
Product code: Code KZI
Device class: Class 1
Regulation: 21 CFR 866.2330
Advisory panel: Microbiology
Date received: 1987-07-07
Decision date: 1987-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laval, Que. H7n-423, CA

Download summary PDF View on FDA.gov ↗

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K872670 — IAFP MAC CONKEY AGAR1987-08-11
K872672 — IAFP BILE ESCULIN AZIDE AGAR1987-08-11
K872673 — I.A.F.P. C.D.C. ANAEROBIC SHEEP BLOOD AGAR W/P.E.A1987-08-11

Adverse events under product code KZI

product code KZI

Malfunction: 2,834
Total: 2,834

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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