510(k) K972129

Device: CHLAMYDIATROL AG
Applicant: BLACKHAWK BIOSYSTEMS, INC.
510(k) number: K972129
Product code: MJZ
Decision: Substantially Equivalent (SESE)
Decision date: 1997-08-12
Date received: 1997-06-06
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: CAROLE POLITO
Address: 12945 Alcosta Blvd. San Ramon CA US 94583 94583

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
K972182	ABBOTT STREP A CONTROLS	Abbott Diagnostics	1997-08-13

Legacy Summary#

summary

FDA Review#

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