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FDA 510(k)

DIGOXIN FPIA CALIBRATORS

K-Number: K872328 · 1987-07-07

ApplicantSigma Chemical Co.
Decision Date1987-07-07
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN FPIA CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1987-07-07 under 510(k) number K872328. 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 DIGOXIN FPIA CALIBRATORS?

DIGOXIN FPIA CALIBRATORS is a medical device that received FDA 510(k) clearance on 1987-07-07. The listed applicant is Sigma Chemical Co.. The 510(k) number is K872328.

When did DIGOXIN FPIA CALIBRATORS receive FDA 510(k) clearance?

DIGOXIN FPIA CALIBRATORS received FDA 510(k) clearance on 1987-07-07, under 510(k) number K872328.

Who is the listed applicant for DIGOXIN FPIA CALIBRATORS?

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

What is the FDA product code for DIGOXIN FPIA CALIBRATORS?

The FDA product code for DIGOXIN FPIA CALIBRATORS is DLJ.

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Other records listing Sigma Chemical Co. 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.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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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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