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FDA 510(k)

CELLMATICS SHLAMYDIA DETECTION SYSTEM

K-Number: K893669 · 1989-06-23

ApplicantDifco Laboratories, Inc.
Decision Date1989-06-23
Product CodeLKH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CELLMATICS SHLAMYDIA DETECTION SYSTEM 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 1989-06-23 under 510(k) number K893669. The device is classified under product code LKH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELLMATICS SHLAMYDIA DETECTION SYSTEM?

CELLMATICS SHLAMYDIA DETECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K893669.

When did CELLMATICS SHLAMYDIA DETECTION SYSTEM receive FDA 510(k) clearance?

CELLMATICS SHLAMYDIA DETECTION SYSTEM received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893669.

Who is the listed applicant for CELLMATICS SHLAMYDIA DETECTION SYSTEM?

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 CELLMATICS SHLAMYDIA DETECTION SYSTEM?

The FDA product code for CELLMATICS SHLAMYDIA DETECTION SYSTEM is LKH.

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Related Devices (Code: LKH)

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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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