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FDA 510(k)

50NG/ML COCAINE METABOLITE CALIBRATOR

K-Number: K972835 · 1997-08-28

ApplicantDiagnostic Reagents, Inc.
Decision Date1997-08-28
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

50NG/ML COCAINE METABOLITE CALIBRATOR 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 1997-08-28 under 510(k) number K972835. 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 50NG/ML COCAINE METABOLITE CALIBRATOR?

50NG/ML COCAINE METABOLITE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1997-08-28. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K972835.

When did 50NG/ML COCAINE METABOLITE CALIBRATOR receive FDA 510(k) clearance?

50NG/ML COCAINE METABOLITE CALIBRATOR received FDA 510(k) clearance on 1997-08-28, under 510(k) number K972835.

Who is the listed applicant for 50NG/ML COCAINE METABOLITE CALIBRATOR?

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 50NG/ML COCAINE METABOLITE CALIBRATOR?

The FDA product code for 50NG/ML COCAINE METABOLITE CALIBRATOR 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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