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FDA 510(k)

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

K-Number: K021997 · 2002-09-25

ApplicantTrek Diagnostic Systems, Inc.
Decision Date2002-09-25
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE 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 2002-09-25 under 510(k) number K021997. 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 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE?

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE is a medical device that received FDA 510(k) clearance on 2002-09-25. The listed applicant is Trek Diagnostic Systems, Inc.. The 510(k) number is K021997.

When did SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE receive FDA 510(k) clearance?

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE received FDA 510(k) clearance on 2002-09-25, under 510(k) number K021997.

Who is the listed applicant for SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE?

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 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE?

The FDA product code for SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE is JWY.

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Other records listing Trek Diagnostic Systems, Inc. as applicant

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Related Devices (Code: 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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