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FDA 510(k)

TOXI CHEM SERUM ALCOHOL CONTROL

K-Number: K833514 · 1983-12-08

ApplicantFisher Diagnostics
Decision Date1983-12-08
Product CodeDKC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TOXI CHEM SERUM ALCOHOL CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Diagnostics. It received FDA 510(k) clearance on 1983-12-08 under 510(k) number K833514. 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 TOXI CHEM SERUM ALCOHOL CONTROL?

TOXI CHEM SERUM ALCOHOL CONTROL is a medical device that received FDA 510(k) clearance on 1983-12-08. The listed applicant is Fisher Diagnostics. The 510(k) number is K833514.

When did TOXI CHEM SERUM ALCOHOL CONTROL receive FDA 510(k) clearance?

TOXI CHEM SERUM ALCOHOL CONTROL received FDA 510(k) clearance on 1983-12-08, under 510(k) number K833514.

Who is the listed applicant for TOXI CHEM SERUM ALCOHOL CONTROL?

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

What is the FDA product code for TOXI CHEM SERUM ALCOHOL CONTROL?

The FDA product code for TOXI CHEM SERUM ALCOHOL CONTROL is DKC.

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Other records listing Fisher 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.

K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsK070640ARCHITECT STAT TROPONIN-1; MYOGLOBINK052407ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLSK052308ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROMK042924ARCHITECT STAT MYO IMMUNOASSAYK041192ARCHITECT STAT TROPONIN-I IMMUNOASSAY

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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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