LIPASE TEST KIT— 510(k) K792289

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K792289 for LIPASE TEST KIT, Substantially Equivalent on 1979-12-18. Applicant: Mallinckrodt Critical Care. Device class: 1.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code CET
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1979-11-13
Decision date: 1979-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Recent devices under product code CET

K970124 — LIPASE REAGENT SET (COLIPASE METHOD)1997-03-06
K940457 — LIPASE REAGENT SYSTEM1994-06-02
K915706 — LIPASE REAGENT SET1992-02-18
K901858 — MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST1990-06-12
K893718 — DELTATEST (R) LIPASE II1989-09-28

More clearances from Mallinckrodt Critical Care

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.