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FDA 510(k)

CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS

K-Number: K860293 · 1986-02-05

ApplicantDifco Laboratories, Inc.
Decision Date1986-02-05
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS is the device name listed in this FDA 510(k) record. The listed applicant is Difco Laboratories, Inc.. It received FDA 510(k) clearance on 1986-02-05 under 510(k) number K860293. The device is classified under product code KIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS?

CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS is a medical device that received FDA 510(k) clearance on 1986-02-05. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K860293.

When did CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS receive FDA 510(k) clearance?

CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS received FDA 510(k) clearance on 1986-02-05, under 510(k) number K860293.

Who is the listed applicant for CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS?

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

What is the FDA product code for CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS?

The FDA product code for CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS is KIR.

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Other records listing Difco Laboratories, Inc. as applicant

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Related Devices (Code: KIR)

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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