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FDA 510(k)

GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT

K-Number: K962217 · 1996-11-27

ApplicantGen-Probe, Inc.
Decision Date1996-11-27
Product CodeMKZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe, Inc.. It received FDA 510(k) clearance on 1996-11-27 under 510(k) number K962217. The device is classified under product code MKZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT?

GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT is a medical device that received FDA 510(k) clearance on 1996-11-27. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K962217.

When did GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT receive FDA 510(k) clearance?

GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT received FDA 510(k) clearance on 1996-11-27, under 510(k) number K962217.

Who is the listed applicant for GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT?

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

What is the FDA product code for GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT?

The FDA product code for GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT is MKZ.

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Other records listing Gen-Probe, Inc. as applicant

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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Related Devices (Code: MKZ)

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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