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FDA 510(k)

AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812

K-Number: K933425 · 1993-11-16

ApplicantSigma Diagnostics, Inc.
Decision Date1993-11-16
Product CodeDKC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-11-16 under 510(k) number K933425. The device is classified under product code DKC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812?

AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 is a medical device that received FDA 510(k) clearance on 1993-11-16. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K933425.

When did AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 receive FDA 510(k) clearance?

AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 received FDA 510(k) clearance on 1993-11-16, under 510(k) number K933425.

Who is the listed applicant for AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812?

The FDA 510(k) record lists Sigma Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812?

The FDA product code for AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 is DKC.

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Other records listing Sigma Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

View all 164 devices →

Related Devices (Code: DKC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K031392MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROLMedical Analysis Systems, Inc.K935819QUALITY CONTROL MATERIAL (ASSAYED)Columbia Diagnostics, Inc.K934467BECKMAN CX AMMONIA/ALCOHOL CONTROLBeckman-Diagnostic Systems GroupK932067ETHANOL CONTROLS, URINE, LEVELS 1,II, AND IIISigma Diagnostics, Inc.K912827SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3Cala DiagnosticsK912826WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2Cala Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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