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510(k) K864438

Device
Beckman Epsilon(tm) Lipase Test Kit
Applicant
BECKMAN INSTRUMENTS, INC.
510(k) number
K864438
Product code
CET
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-12
Date received
1986-11-12
Regulation
862.1465
Classification name
Olive Oil Emulsion (Turbidimetric), Lipase
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
REGINA J O'MEARA
Address
200 S. Kraemer Blvd., W-337 Box 8000 Brea CA US 92622 92622

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CET#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970124LIPASE REAGENT SET (COLIPASE METHOD)Teco Diagnostics1997-03-06
K940457LIPASE REAGENT SYSTEMMedical Diagnostic Technologies, Inc.1994-06-02
K915706LIPASE REAGENT SETTech Intl. Co.1992-02-18
K901858MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TESTE.I. Dupont DE Nemours & Co., Inc.1990-06-12
K893718DELTATEST (R) LIPASE IIElectro-Nucleonics, Inc.1989-09-28
K885078LIPASE SR LIQUID STABLE REAGENT SETMedical Analysis Systems, Inc.1989-03-13
K862440PARAMAX LIPASE REAGENTAmerican Dade1986-08-04
K844240ENZYGNOST LIPASE TESTBehring Diagnostics, Inc.1985-02-12
K823860NUCLIPASE (I125) PANCREATIC LIPASENuclear Diagnostics, Inc.1983-04-18
K812794LIPASEPointe Scientific, Inc.,1981-10-20
K792289LIPASE TEST KITMallinckrodt Critical Care1979-12-18
K791922HARLECO BRAND CLINICARD LIPASE TEST SETDade, Baxter Travenol Diagnostics, Inc.1979-11-27
K790796LIPASE REAGENT SETAlta Diagnostics, Inc.1979-07-17
K770364ACA LIPASE ANALYTICAL TEST PACKE.I. Dupont DE Nemours & Co., Inc.1977-04-15