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FDA 510(k)

QUALITY CONTROL MATERIAL (ASSAYED)

K-Number: K935819 · 1994-03-22

ApplicantColumbia Diagnostics, Inc.
Decision Date1994-03-22
Product CodeDKC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUALITY CONTROL MATERIAL (ASSAYED) is the device name listed in this FDA 510(k) record. The listed applicant is Columbia Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-03-22 under 510(k) number K935819. 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 QUALITY CONTROL MATERIAL (ASSAYED)?

QUALITY CONTROL MATERIAL (ASSAYED) is a medical device that received FDA 510(k) clearance on 1994-03-22. The listed applicant is Columbia Diagnostics, Inc.. The 510(k) number is K935819.

When did QUALITY CONTROL MATERIAL (ASSAYED) receive FDA 510(k) clearance?

QUALITY CONTROL MATERIAL (ASSAYED) received FDA 510(k) clearance on 1994-03-22, under 510(k) number K935819.

Who is the listed applicant for QUALITY CONTROL MATERIAL (ASSAYED)?

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

What is the FDA product code for QUALITY CONTROL MATERIAL (ASSAYED)?

The FDA product code for QUALITY CONTROL MATERIAL (ASSAYED) is DKC.

Related Clinical Trials

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.

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Other records listing Columbia 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.

K854119ACCURACY

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.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

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

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