BUFFERED CHARCOAL YEAST EXTRACT AGAR— 510(k) K802757

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K802757 for BUFFERED CHARCOAL YEAST EXTRACT AGAR, Substantially Equivalent on 1981-01-08. Applicant: Remel Co.. Device class: 1.

Clearance details

Applicant
Remel Co.
Product code
Code JSJ
Device class
Class 1
Regulation
21 CFR 866.2360
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JSJ

product code JSJ
Malfunction
520
Total
520

Source: openFDA MAUDE database, through . 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.