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FDA 510(k)

ANALYST THEOPHYLLINE CALIBRATOR

K-Number: K884170 · 1988-11-16

ApplicantThe DU Pont Co.
Decision Date1988-11-16
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ANALYST THEOPHYLLINE CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is The DU Pont Co.. It received FDA 510(k) clearance on 1988-11-16 under 510(k) number K884170. 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 ANALYST THEOPHYLLINE CALIBRATOR?

ANALYST THEOPHYLLINE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1988-11-16. The listed applicant is The DU Pont Co.. The 510(k) number is K884170.

When did ANALYST THEOPHYLLINE CALIBRATOR receive FDA 510(k) clearance?

ANALYST THEOPHYLLINE CALIBRATOR received FDA 510(k) clearance on 1988-11-16, under 510(k) number K884170.

Who is the listed applicant for ANALYST THEOPHYLLINE CALIBRATOR?

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

What is the FDA product code for ANALYST THEOPHYLLINE CALIBRATOR?

The FDA product code for ANALYST THEOPHYLLINE CALIBRATOR is DLJ.

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Other records listing The DU Pont 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.

K953475CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGINGK953477MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGINGK952891CRONEX LOW ABSORPTION CASSETTEK945125DUPONT ACA VANCOMYCIN (VANC) METHODK943704LIPASE CALIBRATORK900492LABELING CHANGE - VIASPAN(TM) (BELZER UW)

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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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