FDA 510(k)

DIACIDE HD DISINFECTING SOLUTION

K-Number: K944037 · 1995-03-22

Decision Date1995-03-22

Product CodeLRJ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DIACIDE HD DISINFECTING SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Gulfstream Medical. It received FDA 510(k) clearance on 1995-03-22 under 510(k) number K944037. The device is classified under product code LRJ. It was reviewed by the HO advisory panel. Product code LRJ falls under the category of Clinical Lab, which includes general clinical laboratory instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIACIDE HD DISINFECTING SOLUTION?

DIACIDE HD DISINFECTING SOLUTION is a medical device that received FDA 510(k) clearance on 1995-03-22. The listed applicant is Gulfstream Medical. The 510(k) number is K944037.

When did DIACIDE HD DISINFECTING SOLUTION receive FDA 510(k) clearance?

DIACIDE HD DISINFECTING SOLUTION received FDA 510(k) clearance on 1995-03-22, under 510(k) number K944037.

Who is the listed applicant for DIACIDE HD DISINFECTING SOLUTION?

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

What is the FDA product code for DIACIDE HD DISINFECTING SOLUTION?

The FDA product code for DIACIDE HD DISINFECTING SOLUTION is LRJ. This falls under the Clinical Lab category.

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Other records listing Gulfstream Medical as applicant

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Related Devices (Code: LRJ)

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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.