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FDA 510(k)

HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE

K-Number: K951241 · 1995-10-07

ApplicantRadiometer America, Inc.
Decision Date1995-10-07
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1995-10-07 under 510(k) number K951241. 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 HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE?

HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE is a medical device that received FDA 510(k) clearance on 1995-10-07. The listed applicant is Radiometer America, Inc.. The 510(k) number is K951241.

When did HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE receive FDA 510(k) clearance?

HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE received FDA 510(k) clearance on 1995-10-07, under 510(k) number K951241.

Who is the listed applicant for HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE?

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

What is the FDA product code for HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE?

The FDA product code for HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE 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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