510(k) K964781

Device: IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
Applicant: BECKMAN INSTRUMENTS, INC.
510(k) number: K964781
Product code: DDS
Decision: Substantially Equivalent (SESE)
Decision date: 1997-05-09
Date received: 1996-11-27
Regulation: 866.5060
Classification name: Prealbumin, Fitc, Antigen, Antiserum, Control
Medical specialty: Immunology
Review panel: Immunology
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: FRANK MARTE
Address: 200 S. Kraemer Blvd., W-337 Box 8000 Brea CA US 92622 92622

FDA Registration Numbers#

2050012
2517506
2050010
1836161
9680746
3003761012

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
15099590231897	IMMAGE	Beckman Coulter, Inc.	2016-08-24

Other 510(k) Records For Product Code DDS #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K972812	RAICHEM PREALBUMIN SPIA	Hemagen Diagnostics, Inc.	1997-08-28
K934966	SPQ PAL CONTROL LEVEL II	Incstar Corp.	1994-01-11
K854811	ICS PAB PREALBUMIN REAGENT TEST KIT	Beckman Instruments, Inc.	1986-01-24

Legacy Summary#

summary

FDA Review#

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