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FDA 510(k)

WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2

K-Number: K912826 · 1991-07-26

ApplicantCala Diagnostics
Decision Date1991-07-26
Product CodeDKC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 is the device name listed in this FDA 510(k) record. The listed applicant is Cala Diagnostics. It received FDA 510(k) clearance on 1991-07-26 under 510(k) number K912826. 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 WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2?

WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 is a medical device that received FDA 510(k) clearance on 1991-07-26. The listed applicant is Cala Diagnostics. The 510(k) number is K912826.

When did WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 receive FDA 510(k) clearance?

WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 received FDA 510(k) clearance on 1991-07-26, under 510(k) number K912826.

Who is the listed applicant for WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2?

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

What is the FDA product code for WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2?

The FDA product code for WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 is DKC.

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Other records listing Cala Diagnostics 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.

K944247CARDIOCHEX CKMB IMMUNOINHIBITION CONTROLK944246CARDIOCHEX CKMB MASS MEASUREMENT CONTROLK944243CARDIOCHEXK930874LD-1 CONTROL-LEVEL 1 & 2K930875CKMB CONTROL - LEVEL 1,2,3K930873CKMB ISOENZYME CONTROL-LEVEL 1,2.3

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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.

K031392MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROLMedical Analysis Systems, Inc.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 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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