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FDA 510(k)

PHENYTOIN CALIBRATORS

K-Number: K945337 · 1994-12-07

ApplicantDiagnostic Reagents, Inc.
Decision Date1994-12-07
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PHENYTOIN CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1994-12-07 under 510(k) number K945337. 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 PHENYTOIN CALIBRATORS?

PHENYTOIN CALIBRATORS is a medical device that received FDA 510(k) clearance on 1994-12-07. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K945337.

When did PHENYTOIN CALIBRATORS receive FDA 510(k) clearance?

PHENYTOIN CALIBRATORS received FDA 510(k) clearance on 1994-12-07, under 510(k) number K945337.

Who is the listed applicant for PHENYTOIN CALIBRATORS?

The FDA 510(k) record lists Diagnostic Reagents, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHENYTOIN CALIBRATORS?

The FDA product code for PHENYTOIN CALIBRATORS is DLJ.

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Other records listing Diagnostic Reagents, 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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

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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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