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FDA 510(k)

THEOPHYLLINE FPIA CONTROLS

K-Number: K871589 · 1987-06-17

ApplicantSigma Chemical Co.
Decision Date1987-06-17
Product CodeLAW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THEOPHYLLINE FPIA CONTROLS 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 1987-06-17 under 510(k) number K871589. The device is classified under product code LAW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THEOPHYLLINE FPIA CONTROLS?

THEOPHYLLINE FPIA CONTROLS is a medical device that received FDA 510(k) clearance on 1987-06-17. The listed applicant is Sigma Chemical Co.. The 510(k) number is K871589.

When did THEOPHYLLINE FPIA CONTROLS receive FDA 510(k) clearance?

THEOPHYLLINE FPIA CONTROLS received FDA 510(k) clearance on 1987-06-17, under 510(k) number K871589.

Who is the listed applicant for THEOPHYLLINE FPIA CONTROLS?

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 THEOPHYLLINE FPIA CONTROLS?

The FDA product code for THEOPHYLLINE FPIA CONTROLS is LAW.

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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: LAW)

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.

K920223CHEM CHEX THEOPHYLLINE CONTROLStreck Laboratories, Inc.K914251MODEL IRC PASSPORT NEBULIZERInvacare Corp.K903924BIOTRACK THEOPHYLLINE QUALITY CONTROLSBiotrack, 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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