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FDA 510(k)

GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS

K-Number: K874878 · 1987-12-29

ApplicantGen-Probe, Inc.
Decision Date1987-12-29
Product CodeLSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS 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 1987-12-29 under 510(k) number K874878. The device is classified under product code LSK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS?

GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS is a medical device that received FDA 510(k) clearance on 1987-12-29. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K874878.

When did GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS receive FDA 510(k) clearance?

GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS received FDA 510(k) clearance on 1987-12-29, under 510(k) number K874878.

Who is the listed applicant for GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS?

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(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS?

The FDA product code for GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS is LSK.

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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: LSK)

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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