510(k) K885263

Device: QMS(TM) - THEOPHYLLINE
Applicant: SERADYN, INC.
510(k) number: K885263
Product code: JQX
Decision: Substantially Equivalent (SESE)
Decision date: 1989-03-28
Date received: 1988-12-23
Regulation: 862.2700
Classification name: Nephelometer, For Clinical Use
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Contact: J SULLIVAN
Address: P.O. Box 1210 Indianapolis IN US 46206 46206

FDA Registration Numbers#

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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JQX #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K962294	IMMAGE IMMUNOCHEMISTRY SYSTEM	Beckman Instruments, Inc.	1996-08-21
K922273	ARRAY(R) 360	Beckman Instruments, Inc.	1992-08-19
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#

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