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FDA 510(k)

OPTION U1 FOR THE DPS-PLUS SYSTEM

K-Number: K915305 · 1992-02-26

ApplicantAdac Laboratories
Decision Date1992-02-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPTION U1 FOR THE DPS-PLUS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Adac Laboratories. It received FDA 510(k) clearance on 1992-02-26 under 510(k) number K915305. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTION U1 FOR THE DPS-PLUS SYSTEM?

OPTION U1 FOR THE DPS-PLUS SYSTEM is a medical device that received FDA 510(k) clearance on 1992-02-26. The listed applicant is Adac Laboratories. The 510(k) number is K915305.

When did OPTION U1 FOR THE DPS-PLUS SYSTEM receive FDA 510(k) clearance?

OPTION U1 FOR THE DPS-PLUS SYSTEM received FDA 510(k) clearance on 1992-02-26, under 510(k) number K915305.

Who is the listed applicant for OPTION U1 FOR THE DPS-PLUS SYSTEM?

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

What is the FDA product code for OPTION U1 FOR THE DPS-PLUS SYSTEM?

The FDA product code for OPTION U1 FOR THE DPS-PLUS SYSTEM is LLZ.

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Other records listing Adac Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K062298APOLLO GAMMA CAMERA SYSTEMK061029JETSTREAM WORKSPACEK060020AUTOQUANT PLUSK051351PRECEDENCE SPECT/CT IMAGING SYSTEMK042880JETSTREAM WORKSPACEK042903AUTOSPECS

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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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