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FDA 510(k)

CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST

K-Number: K870864 · 1987-04-14

ApplicantMarion Laboratories, Inc.
Decision Date1987-04-14
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Marion Laboratories, Inc.. It received FDA 510(k) clearance on 1987-04-14 under 510(k) number K870864. The device is classified under product code LLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST?

CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST is a medical device that received FDA 510(k) clearance on 1987-04-14. The listed applicant is Marion Laboratories, Inc.. The 510(k) number is K870864.

When did CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST receive FDA 510(k) clearance?

CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST received FDA 510(k) clearance on 1987-04-14, under 510(k) number K870864.

Who is the listed applicant for CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST?

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

What is the FDA product code for CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST?

The FDA product code for CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST is LLH.

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Other records listing Marion Laboratories, Inc. as applicant

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Related Devices (Code: LLH)

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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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