MOTILITY GI MEDIUM— 510(k) K812798

Name: FDA 510(k) clearance K812798
Creator: U.S. Food and Drug Administration
Published: 1981-10-20

Substantially Equivalent

Isle Media and Sterile Products, Inc.

FDA 510(k) clearance K812798 for MOTILITY GI MEDIUM, Substantially Equivalent on 1981-10-20. Applicant: Isle Media and Sterile Products, Inc.. Device class: 1.

Clearance details

Applicant: Isle Media and Sterile Products, Inc.
Product code: Code JSG
Device class: Class 1
Regulation: 21 CFR 866.2300
Advisory panel: Microbiology
Date received: 1981-10-06
Decision date: 1981-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSG

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K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T30071988-07-01
K881522 — DEXTROSE AGAR1988-04-18
K881523 — DEXTROSE TRYPTONE BROTH1988-04-18
K881525 — COOKED MEAT MEDIUM1988-04-18
K881528 — CASEIN PEPTONE, LOW VITAMIN1988-04-18

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 JSG

product code JSG

Malfunction: 817
Total: 817

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.