COLUMBIZ CNA AGAR W/15% SHEEP BLOOD— 510(k) K820554

Name: FDA 510(k) clearance K820554
Creator: U.S. Food and Drug Administration
Published: 1982-03-16

Substantially Equivalent

American Laboratory Supply, Inc.

FDA 510(k) clearance K820554 for COLUMBIZ CNA AGAR W/15% SHEEP BLOOD, Substantially Equivalent on 1982-03-16. Applicant: American Laboratory Supply, Inc.. Device class: 1.

Clearance details

Applicant: American Laboratory Supply, Inc.
Product code: Code JSJ
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1982-03-02
Decision date: 1982-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSJ

view all

K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P34211988-06-22
K881524 — DERMATOPHYTE TEST MEDIUM1988-04-18
K881526 — CHAPMAN STONE MEDIUM1988-04-18
K881530 — BRILLIANT GREEN AGAR W/SULFADIAZINE1988-04-18
K881544 — LITTMAN AGAR1988-04-18

More clearances from American Laboratory Supply, Inc.

view all

K852578 — CLED AGAR1985-07-12
K844929 — INHIBITORY MOLD AGAR1985-02-27
K844930 — BRILLANT GREEN AGAR1985-02-27
K844931 — MYCOLOGICAL AGAR W/ANTIBIOTICS1985-02-27
K844932 — MALT AGAR1985-02-27

Adverse events under product code JSJ

product code JSJ

Malfunction: 520
Total: 520

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.