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FDA 510(k)

DOCUMENT TDM ULTRA UNASSAYED CONTROL

K-Number: K955155 · 1995-12-20

ApplicantCasco Standards
Decision Date1995-12-20
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DOCUMENT TDM ULTRA UNASSAYED CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Casco Standards. It received FDA 510(k) clearance on 1995-12-20 under 510(k) number K955155. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOCUMENT TDM ULTRA UNASSAYED CONTROL?

DOCUMENT TDM ULTRA UNASSAYED CONTROL is a medical device that received FDA 510(k) clearance on 1995-12-20. The listed applicant is Casco Standards. The 510(k) number is K955155.

When did DOCUMENT TDM ULTRA UNASSAYED CONTROL receive FDA 510(k) clearance?

DOCUMENT TDM ULTRA UNASSAYED CONTROL received FDA 510(k) clearance on 1995-12-20, under 510(k) number K955155.

Who is the listed applicant for DOCUMENT TDM ULTRA UNASSAYED CONTROL?

The FDA 510(k) record lists Casco Standards as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOCUMENT TDM ULTRA UNASSAYED CONTROL?

The FDA product code for DOCUMENT TDM ULTRA UNASSAYED CONTROL is DIF.

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Related Devices (Code: DIF)

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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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