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FDA 510(k)

HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE

K-Number: K012895 · 2001-10-30

ApplicantTrek Diagnostic Systems, Inc.
Decision Date2001-10-30
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE is the device name listed in this FDA 510(k) record. The listed applicant is Trek Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 2001-10-30 under 510(k) number K012895. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE?

HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE is a medical device that received FDA 510(k) clearance on 2001-10-30. The listed applicant is Trek Diagnostic Systems, Inc.. The 510(k) number is K012895.

When did HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE receive FDA 510(k) clearance?

HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE received FDA 510(k) clearance on 2001-10-30, under 510(k) number K012895.

Who is the listed applicant for HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE?

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

What is the FDA product code for HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE?

The FDA product code for HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE is JWY.

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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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