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FDA 510(k)

DIGITOXIN FPIA CALIBRATOR SET

K-Number: K915464 · 1992-01-15

ApplicantSigma Diagnostics, Inc.
Decision Date1992-01-15
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGITOXIN FPIA CALIBRATOR SET 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 1992-01-15 under 510(k) number K915464. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITOXIN FPIA CALIBRATOR SET?

DIGITOXIN FPIA CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 1992-01-15. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K915464.

When did DIGITOXIN FPIA CALIBRATOR SET receive FDA 510(k) clearance?

DIGITOXIN FPIA CALIBRATOR SET received FDA 510(k) clearance on 1992-01-15, under 510(k) number K915464.

Who is the listed applicant for DIGITOXIN FPIA CALIBRATOR SET?

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 DIGITOXIN FPIA CALIBRATOR SET?

The FDA product code for DIGITOXIN FPIA CALIBRATOR SET is DLJ.

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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

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Related Devices (Code: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)Dade 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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