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FDA 510(k)

SENSITITRE SUSCEPTIBILITY PLATES

K-Number: K923045 · 1993-03-09

ApplicantRadiometer America, Inc.
Decision Date1993-03-09
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE SUSCEPTIBILITY PLATES 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 1993-03-09 under 510(k) number K923045. 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 SUSCEPTIBILITY PLATES?

SENSITITRE SUSCEPTIBILITY PLATES is a medical device that received FDA 510(k) clearance on 1993-03-09. The listed applicant is Radiometer America, Inc.. The 510(k) number is K923045.

When did SENSITITRE SUSCEPTIBILITY PLATES receive FDA 510(k) clearance?

SENSITITRE SUSCEPTIBILITY PLATES received FDA 510(k) clearance on 1993-03-09, under 510(k) number K923045.

Who is the listed applicant for SENSITITRE SUSCEPTIBILITY PLATES?

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 SENSITITRE SUSCEPTIBILITY PLATES?

The FDA product code for SENSITITRE SUSCEPTIBILITY PLATES 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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