510(k) K810119

Device: CONTROL SERUMS FOR NONTREPONEMAL TEST
Applicant: HILLSIDE ACRES, INC.
510(k) number: K810119
Product code: GMP
Decision: Substantially Equivalent (SESE)
Decision date: 1981-02-09
Date received: 1981-01-16
Regulation: 866.3820
Classification name: Antisera, Control For Nontreponemal Tests
Medical specialty: Microbiology
Review panel: Toxicology
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

1641328
1119779
2029372
2242436
2250030

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GMP #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K980638	ADI SYPHILIS RPR LIQUID CONTROLS	Ampcor Diagnostics, Inc.	1998-07-06
K961998	QUALITROL SYPHSERO CONTROL SET	Consolidated Technologies, Inc.	1996-08-08
K955143	RPR LIQUID CONTROLS	Remel, L.P.	1996-07-30
K885298	VISUWELL REAGIN TEST 960 TEST KIT	Allelix Diagnostics, Inc.	1989-03-15
K875180	V-TREND RPRL CARD TEST	Texas Immunology, Inc.	1988-02-04
K851504	VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010	Ncs Diagnostics, Inc.	1985-08-19
K843741	RPR TEST REDITEST	Biokit USA, Inc.	1984-10-25
K812425	BECKMAN R.PR CONTROL SERUM SET	Beckman Instruments, Inc.	1981-09-23

Legacy Summary#

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