NEEDLE COUNTER-SURE COUNT/10 COUNT— 510(k) K801258

Name: FDA 510(k) clearance K801258
Creator: U.S. Food and Drug Administration
Published: 1980-06-04

Substantially Equivalent

Kleen Test Products

FDA 510(k) clearance K801258 for NEEDLE COUNTER-SURE COUNT/10 COUNT, Substantially Equivalent on 1980-06-04. Applicant: Kleen Test Products. Device class: 1.

Clearance details

Applicant: Kleen Test Products
Product code: Code BXX
Device class: Class 1
Regulation: 21 CFR 868.2620
Advisory panel: Anesthesiology
Date received: 1980-05-28
Decision date: 1980-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BXX

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K923397 — SINGLE DOSE GAS INJECTOR1992-09-14
K875075 — RT-200 COMPUTER INTERFACE1988-04-21
K850029 — UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL1985-04-29
K822746 — RT-200 CALIBRATION ANALYZER1982-10-13
K801256 — NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY1980-06-04

More clearances from Kleen Test Products

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K890039 — KLEEN TEST BASIN SET1989-10-24
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K890098 — KLEEN TEST O.R. KIT1989-01-24
K853622 — SURE COUNT 30 COUNT FOAM & MAGNETIC 92-30301985-10-10
K853454 — SURE COUNT 5 & 10 SPONGE COUNTER1985-09-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.