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FDA 510(k)

OUT-RITE WASTE DISPOSABLE BAG

K-Number: K821396 · 1982-06-09

ApplicantKleen Test Products
Decision Date1982-06-09
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OUT-RITE WASTE DISPOSABLE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Kleen Test Products. It received FDA 510(k) clearance on 1982-06-09 under 510(k) number K821396. 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 OUT-RITE WASTE DISPOSABLE BAG?

OUT-RITE WASTE DISPOSABLE BAG is a medical device that received FDA 510(k) clearance on 1982-06-09. The listed applicant is Kleen Test Products. The 510(k) number is K821396.

When did OUT-RITE WASTE DISPOSABLE BAG receive FDA 510(k) clearance?

OUT-RITE WASTE DISPOSABLE BAG received FDA 510(k) clearance on 1982-06-09, under 510(k) number K821396.

Who is the listed applicant for OUT-RITE WASTE DISPOSABLE BAG?

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

What is the FDA product code for OUT-RITE WASTE DISPOSABLE BAG?

The FDA product code for OUT-RITE WASTE DISPOSABLE BAG is LDQ.

Related Clinical Trials

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Other records listing Kleen Test Products 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.

K890039KLEEN TEST BASIN SETK890539SURE COUNT LIGHT HANDLE COVERK890098KLEEN TEST O.R. KITK853622SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030K853454SURE COUNT 5 & 10 SPONGE COUNTERK853315CAUTERY TIP CLEANING PAD

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Related Devices (Code: LDQ)

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.

K993797EC-7701 FLUID WARMING CABINETEnthermics Medical Systems, Inc.K992258HOT SHOT FLUID WARMER IV FLUIDSInfra-Med Technologies, Inc.K981032PIV SYSTEMMedical Solutions, Inc.K973747CONTROLLED TEMPERATURE CABINET SYSTEMSmithK955661ACU-HALTGlederer & Co., Inc.K955776ACU-LABGlederer & Co., Inc.

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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