SPAC TM T3 UPTAKE KIT— 510(k) K770033

Name: FDA 510(k) clearance K770033
Creator: U.S. Food and Drug Administration
Published: 1977-02-07

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K770033 for SPAC TM T3 UPTAKE KIT, Substantially Equivalent on 1977-02-07. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1977-01-10
Decision date: 1977-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHQ

view all

K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS1998-06-10
K980088 — T-UPTAKE MICROPLATE EIA1998-02-04
K970539 — CHIRON DIAGNOSTICS ACS:180TU P1997-03-24
K964308 — VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)1996-11-27
K961488 — ELECSYS T-UPTAKE ASSAY1996-06-12

More clearances from Mallinckrodt Critical Care

view all

K880343 — BURNEY GALLBLADDER CATHETER KIT1989-05-01
K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR1988-02-02
K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE1988-01-29
K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR1988-01-06
K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)1987-11-06

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