510(k) K972182

Device: ABBOTT STREP A CONTROLS
Applicant: ABBOTT DIAGNOSTICS
510(k) number: K972182
Product code: MJZ
Decision: Substantially Equivalent (SESE)
Decision date: 1997-08-13
Date received: 1997-05-29
Regulation: 862.1660
Classification name: Kit, Direct Antigen, Positive Control
Medical specialty: Clinical Chemistry
Review panel: Microbiology
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: GRACE LEMIEUX
Address: 200 Abbott Park Rd. Dept. 9v6, Bldg. Ap31 Abbott Park IL US 60064 60064

FDA Registration Numbers#

1221359
3007606081
3017662853
3014150341
3023322455
3004635103
3004146366
3016252795

Source Documents#

Other 510(k) Records For Product Code MJZ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K083744	BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010	Binax, Inc.	2009-09-01
K972129	CHLAMYDIATROL AG	Blackhawk Biosystems, Inc.	1997-08-12

Legacy Summary#

summary

FDA Review#

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