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FDA 510(k)

CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT

K-Number: K834115 · 1984-03-23

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1984-03-23
Product CodeJSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT is the device name listed in this FDA 510(k) record. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K834115. The device is classified under product code JSK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT?

CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K834115.

When did CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT receive FDA 510(k) clearance?

CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT received FDA 510(k) clearance on 1984-03-23, under 510(k) number K834115.

Who is the listed applicant for CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT?

The FDA 510(k) record lists Bartels Immunodiagnostic Supplies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT?

The FDA product code for CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT is JSK.

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Other records listing Bartels Immunodiagnostic Supplies, Inc. as applicant

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Related Devices (Code: JSK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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