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FDA 510(k)

NEEDLE COUNTER-SURE COUNT/10 COUNT

K-Number: K801258 · 1980-06-04

ApplicantKleen Test Products
Decision Date1980-06-04
Product CodeBXX
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEEDLE COUNTER-SURE COUNT/10 COUNT 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 1980-06-04 under 510(k) number K801258. The device is classified under product code BXX. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEEDLE COUNTER-SURE COUNT/10 COUNT?

NEEDLE COUNTER-SURE COUNT/10 COUNT is a medical device that received FDA 510(k) clearance on 1980-06-04. The listed applicant is Kleen Test Products. The 510(k) number is K801258.

When did NEEDLE COUNTER-SURE COUNT/10 COUNT receive FDA 510(k) clearance?

NEEDLE COUNTER-SURE COUNT/10 COUNT received FDA 510(k) clearance on 1980-06-04, under 510(k) number K801258.

Who is the listed applicant for NEEDLE COUNTER-SURE COUNT/10 COUNT?

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 NEEDLE COUNTER-SURE COUNT/10 COUNT?

The FDA product code for NEEDLE COUNTER-SURE COUNT/10 COUNT is BXX.

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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: BXX)

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.

K923397SINGLE DOSE GAS INJECTOREscalon Medical TrekK875075RT-200 COMPUTER INTERFACETimeter Instrument Corp.K850029UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CALUtah Medical Products, Inc.K822746RT-200 CALIBRATION ANALYZERTimeter Instrument Corp.K801257NEEDLE COUNTER-SURE COUNT/30 CT. MAGN.Kleen Test ProductsK801256NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAYKleen Test Products

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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