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FDA 510(k)

SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES

K-Number: K936305 · 1995-07-13

ApplicantRadiometer America, Inc.
Decision Date1995-07-13
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE/PIP/TA2 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 1995-07-13 under 510(k) number K936305. 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/PIP/TA2 SUSCEPTIBILITY PLATES?

SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES is a medical device that received FDA 510(k) clearance on 1995-07-13. The listed applicant is Radiometer America, Inc.. The 510(k) number is K936305.

When did SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES receive FDA 510(k) clearance?

SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES received FDA 510(k) clearance on 1995-07-13, under 510(k) number K936305.

Who is the listed applicant for SENSITITRE/PIP/TA2 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/PIP/TA2 SUSCEPTIBILITY PLATES?

The FDA product code for SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES is JWY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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