WILKENS CHALGREN BROTH— 510(k) K881568

Name: FDA 510(k) clearance K881568
Creator: U.S. Food and Drug Administration
Published: 1988-04-18

Substantially Equivalent

Acumedia Manufacturers, Inc.

FDA 510(k) clearance K881568 for WILKENS CHALGREN BROTH, Substantially Equivalent on 1988-04-18. Applicant: Acumedia Manufacturers, Inc.. Device class: 2.

Clearance details

Applicant: Acumedia Manufacturers, Inc.
Product code: Code JSO
Device class: Class 2
Regulation: 21 CFR 866.1700
Advisory panel: Microbiology
Date received: 1988-04-11
Decision date: 1988-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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K881523 — DEXTROSE TRYPTONE BROTH1988-04-18
K881524 — DERMATOPHYTE TEST MEDIUM1988-04-18
K881525 — COOKED MEAT MEDIUM1988-04-18

Adverse events under product code JSO

product code JSO

Malfunction: 602
Total: 602

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.