CAMPY 5H— 510(k) K834326

Name: FDA 510(k) clearance K834326
Creator: U.S. Food and Drug Administration
Published: 1984-01-12

Substantially Equivalent

Hardy Media

FDA 510(k) clearance K834326 for CAMPY 5H, Substantially Equivalent on 1984-01-12. Applicant: Hardy Media. Device class: 1.

Clearance details

Applicant: Hardy Media
Product code: Code JSJ
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1983-12-09
Decision date: 1984-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSJ

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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 Hardy Media

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K880116 — MRVP BROTH1988-03-31
K880119 — MOELLERS DECARBOXYLASE, ONITHINE1988-03-31
K880120 — MOELLERS DECARBOXYLASE, LYSINE1988-03-31
K880121 — MOELLERS DECARBOXYLASE, BASE1988-03-31
K880122 — MIDDLEBROOK 7H9 BROTH1988-03-31

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.