510(k) K962294

Device: IMMAGE IMMUNOCHEMISTRY SYSTEM
Applicant: BECKMAN INSTRUMENTS, INC.
510(k) number: K962294
Product code: JQX
Decision: Substantially Equivalent (SESE)
Decision date: 1996-08-21
Date received: 1996-06-14
Regulation: 862.2700
Classification name: Nephelometer, For Clinical Use
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: SHERI HALL
Address: 200 S. Kraemer Blvd. W-337 Brea CA US 92821 92821

FDA Registration Numbers#

3008517993
1119779
1111096
1924669
3009238284
3027977508
3038188172
2050012
3006786907
3006198300
1530126
8021914
3008862790

Source Documents#

Other 510(k) Records For Product Code JQX #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K922273	ARRAY(R) 360	Beckman Instruments, Inc.	1992-08-19
K885263	QMS(TM) - THEOPHYLLINE	Seradyn, Inc.	1989-03-28
K851253	TDX ANALYZER W/NEPHELOMETRY CAROUSEL	Abbott Laboratories	1985-04-30
K851234	A-JUST TURBIDITY METER	Abbott Laboratories	1985-04-29
K801362	ALBUMIN NEPHELOMETRIC ASSAY	J.T. Baker Chemical Co.	1980-07-21
K801089	J.T. BAKER NEPHELOMETER	J.T. Baker Chemical Co.	1980-05-28
K792045	BIOVATION NEPHELOMETER	Biovation, Inc.	1979-10-30
K790103	NEPHELOMETER, MIC-2000 LASER	Dynatech Corp.	1979-03-12
K781554	RAD-291	Organon, Inc.	1978-10-11
K781644	ANTIBIOTIC NEPHELOMETER	Biovation, Inc.	1978-10-03
K780251	NEPHELOMETER	Kallestad Laboratories, Inc.	1978-04-06
K772361	LASER IMMUNONEPHELOMETRIC ANALYZER	G.D. Searle and Co.	1978-01-30
K771446	TRANSPORTEO MODULE	Hyland Therapeutic Div., Travenol Laboratories	1977-08-10

Legacy Summary#

summary

FDA Review#

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