FDA 510(k)

ACU-LAB

K-Number: K955776 · 1996-06-05

Decision Date1996-06-05

Product CodeLDQ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ACU-LAB is the device name listed in this FDA 510(k) record. The listed applicant is Glederer & Co., Inc.. It received FDA 510(k) clearance on 1996-06-05 under 510(k) number K955776. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACU-LAB?

ACU-LAB is a medical device that received FDA 510(k) clearance on 1996-06-05. The listed applicant is Glederer & Co., Inc.. The 510(k) number is K955776.

When did ACU-LAB receive FDA 510(k) clearance?

ACU-LAB received FDA 510(k) clearance on 1996-06-05, under 510(k) number K955776.

Who is the listed applicant for ACU-LAB?

The FDA 510(k) record lists Glederer & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACU-LAB?

The FDA product code for ACU-LAB is LDQ.

Other records listing Glederer & Co., Inc. 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.

K955661ACU-HALT

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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.