510(k) K842579

Device: B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS
Applicant: BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES
510(k) number: K842579
Product code: JTR
Decision: Substantially Equivalent (SESE)
Decision date: 1984-07-27
Date received: 1984-07-03
Regulation: 866.2480
Classification name: Kit, Quality Control For Culture Media
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

2150138
2030538
3015715780
3006091463
1050138
2436875
1924669
2518630
9610649

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JTR #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K871121	PROTECT T.M.	Pro-Lab, Inc.	1987-04-14
K862914	FEKAL CHECK PARASITOLOGY CONTROL SLIDE	Trend Scientific, Inc.	1986-09-16
K861022	KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS	Micro-Bio-Logics	1986-04-04
K855198	INDI KWIK (TM) CO/TWO KIT	Micro-Bio-Logics	1986-01-14
K842129	LYFO-DISK MICROORGANISMS	Micro-Bio-Logics	1984-07-03
K831653	LYOPHILIZED MICROORGANISMS	Austin Biological Laboratories	1983-07-28
K830133	Q-CHECK CULTI-LOOPS	Lab Ability, Inc.	1983-02-09
K822954	MICROTECH BACTERIAL CONTROLS	Universal Micro Reference Laboratory	1982-11-16
K821660	BIO-CHECK GRAM STAIN CONTROL	American Scientific Products	1982-06-25
K820064	SUSCEPTROL	American Type Culture Collection	1982-01-28
K812698	GC DISK	Remel Co.	1981-10-06

Legacy Summary#

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