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FDA 510(k)

GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR

K-Number: K940979 · 1994-10-31

ApplicantGen-Probe, Inc.
Decision Date1994-10-31
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR 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 1994-10-31 under 510(k) number K940979. The device is classified under product code LSL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR?

GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR is a medical device that received FDA 510(k) clearance on 1994-10-31. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K940979.

When did GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR receive FDA 510(k) clearance?

GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR received FDA 510(k) clearance on 1994-10-31, under 510(k) number K940979.

Who is the listed applicant for GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR?

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 PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR?

The FDA product code for GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR is LSL.

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Other records listing Gen-Probe, Inc. as applicant

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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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