CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT

Supplement, Culture Media

BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC.

The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Cultrol-antibiotic/antimycotic Solut.

Pre-market Notification Details

Device IDK834115
510k NumberK834115
Device Name:CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT
ClassificationSupplement, Culture Media
Applicant BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSK  
CFR Regulation Number866.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-29
Decision Date1984-03-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05391516747325 K834115 000
05391516747318 K834115 000

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