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510(k) K053612

Device
DRI-STAT ACID PHOSPHATASE REAGENT
Applicant
BECKMAN COULTER, INC.
510(k) number
K053612
Product code
CKB  
Decision
Substantially Equivalent (SESE)
Decision date
2006-04-26
Date received
2005-12-27
Regulation
862.1020
Classification name
Acid Phosphatase, Naphthyl Phosphate
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ERI HIRUMI
Address
200 S. Kraemer Blvd. W-110 Brea CA US 92822 92822

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CKB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023840ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650Bayer Diagnostics Corp.2003-01-07
K991010ACPAbbott Diagnostics Mfg., Inc.1999-05-19
K981743OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZEROlympus America, Inc.1998-06-09
K974695COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)Roche Diagnostic Systems, Inc.1998-05-21
K963640OLYMPUS ACID PHOSPHATASE REAGENTOlympus America, Inc.1997-02-18
K943366IL TEST ACID PHOSPHATASEInstrumentation Laboratory CO1996-01-29
K902543ACID PHOSPHOTASE REAGENT TEST AND KITCrestat Diagnostics, Inc.1990-09-07
K902495ACID PHOSPHATASE REAGENT SETTech Intl. Co.1990-07-16
K892393ACID PHOSPHATASE REAGENTMedical Analysis Systems, Inc.1989-07-20
K884747TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)Technicon Instruments Corp.1989-01-30
K881204ACP KINETIC TEST (ACID PHOSPHATASE TEST)Sclavo, Inc.1988-04-28
K880798ACID PHOSPHATASE REAGENTTrace America, Inc.1988-04-18
K875209ACID PHOSPHATASE (KINETIC) CAT. # 320-06Diagnostic Chemicals, Ltd. (Usa)1988-02-01
K863851ACID PHOSPHATASE (ACP) REAGENTSigma Diagnostics, Inc.1986-10-16
K861675ACID PHOSPHATASE PROCEDUREData Medical Associates, Inc.1986-05-29

Legacy Summary#

summary

FDA Review#

Decision Summary