PHENYLETHANOL AGAR— 510(k) K792593

Name: FDA 510(k) clearance K792593
Creator: U.S. Food and Drug Administration
Published: 1979-12-31

Substantially Equivalent

Isle Media and Sterile Products, Inc.

FDA 510(k) clearance K792593 for PHENYLETHANOL AGAR, Substantially Equivalent on 1979-12-31. Applicant: Isle Media and Sterile Products, Inc.. Device class: 1.

Clearance details

Applicant: Isle Media and Sterile Products, Inc.
Product code: Code JSJ
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1979-12-17
Decision date: 1979-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K881526 — CHAPMAN STONE MEDIUM1988-04-18
K881530 — BRILLIANT GREEN AGAR W/SULFADIAZINE1988-04-18
K881544 — LITTMAN AGAR1988-04-18

More clearances from Isle Media and Sterile Products, Inc.

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K831671 — MODIFIED SOYBEAN CASEIN DIGEST BROTH1983-07-28
K821218 — CAMPY-S AGAR1982-05-14
K820863 — MEDIA FOR IN-VITRO DIAGNOSTIC USE1982-04-16
K812795 — ANAEROBIC BLOOD AGAR1981-10-20
K812796 — ANAEROBIC CNA BLOOD AGAR1981-10-20

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.