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FDA 510(k)

MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL

K-Number: K031392 · 2003-07-01

ApplicantMedical Analysis Systems, Inc.
Decision Date2003-07-01
Product CodeDKC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 2003-07-01 under 510(k) number K031392. 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 MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL?

MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL is a medical device that received FDA 510(k) clearance on 2003-07-01. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K031392.

When did MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL receive FDA 510(k) clearance?

MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL received FDA 510(k) clearance on 2003-07-01, under 510(k) number K031392.

Who is the listed applicant for MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL?

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

What is the FDA product code for MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL?

The FDA product code for MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL is DKC.

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Other records listing Medical Analysis Systems, 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.

K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROLK041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND HK040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3K032826MAS PAR TDMK032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TLK031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

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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.

K935819QUALITY CONTROL MATERIAL (ASSAYED)Columbia Diagnostics, Inc.K933425AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812Sigma 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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