510(k) K933425

Device: AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812
Applicant: SIGMA DIAGNOSTICS, INC.
510(k) number: K933425
Product code: DKC
Decision: Substantially Equivalent (SESE)
Decision date: 1993-11-16
Date received: 1993-07-13
Regulation: 862.3280
Classification name: Alcohol Control Materials
Medical specialty: Toxicology
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Statement or summary: Statement
Third party reviewed: No

Applicant Contact#

Contact: LEO BRESSLER
Address: 545 S. Ewing Ave. St. Louis MO US 63103 63103

FDA Registration Numbers#

3010939897
2030861
3003610499
3003951180
1827821
2050010
2020952
3005333358
2050012
2085064

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DKC #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K031392	MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL	Medical Analysis Systems, Inc.	2003-07-01
K935819	QUALITY CONTROL MATERIAL (ASSAYED)	Columbia Diagnostics, Inc.	1994-03-22
K934467	BECKMAN CX AMMONIA/ALCOHOL CONTROL	Beckman-Diagnostic Systems Group	1993-10-27
K932067	ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III	Sigma Diagnostics, Inc.	1993-06-16
K912827	SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3	Cala Diagnostics	1991-08-12
K912826	WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2	Cala Diagnostics	1991-07-26
K843872	ETHANOL CONTROLS LOW & HIGH E5133/E5258	Sigma Chemical Co.	1984-10-31
K833514	TOXI CHEM SERUM ALCOHOL CONTROL	Fisher Diagnostics	1983-12-08
K810465	EMIT-ST ETHYL ALCOHOL SERUM CONTROLS	Syva Co.	1981-03-06
K802618	EMIT-STM ETHYL ALCOHOL URINE CONTROLS	Syva Co.	1980-10-31

Legacy Summary#

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