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FDA 510(k)

ACCUCOLOR HIGH CALIBRATOR (A3089)

K-Number: K973274 · 1997-10-31

ApplicantSigma Diagnostics, Inc.
Decision Date1997-10-31
Product CodeGIZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACCUCOLOR HIGH CALIBRATOR (A3089) 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 1997-10-31 under 510(k) number K973274. The device is classified under product code GIZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUCOLOR HIGH CALIBRATOR (A3089)?

ACCUCOLOR HIGH CALIBRATOR (A3089) is a medical device that received FDA 510(k) clearance on 1997-10-31. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K973274.

When did ACCUCOLOR HIGH CALIBRATOR (A3089) receive FDA 510(k) clearance?

ACCUCOLOR HIGH CALIBRATOR (A3089) received FDA 510(k) clearance on 1997-10-31, under 510(k) number K973274.

Who is the listed applicant for ACCUCOLOR HIGH CALIBRATOR (A3089)?

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 ACCUCOLOR HIGH CALIBRATOR (A3089)?

The FDA product code for ACCUCOLOR HIGH CALIBRATOR (A3089) is GIZ.

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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: GIZ)

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.

K060968STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOWWortham Laboratories, Inc.K042941DADE BEHRING HEPARIN CALIBRATOR AND CONTROLSDade Behring, Inc.K023309CONTROL PLASMA NDade Behring, Inc.K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10Precision BiologicK003328ACCUCLOT CONTROL I, MODEL A4089Sigma Diagnostics, Inc.K001256CONTROL PLASMA NDade Behring, Inc.

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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