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FDA 510(k)

BARBITURATE EIA ESSAY (MODIFICATION)

K-Number: K955928 · 1996-03-11

ApplicantDiagnostic Reagents, Inc.
Decision Date1996-03-11
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BARBITURATE EIA ESSAY (MODIFICATION) 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 1996-03-11 under 510(k) number K955928. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARBITURATE EIA ESSAY (MODIFICATION)?

BARBITURATE EIA ESSAY (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-03-11. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K955928.

When did BARBITURATE EIA ESSAY (MODIFICATION) receive FDA 510(k) clearance?

BARBITURATE EIA ESSAY (MODIFICATION) received FDA 510(k) clearance on 1996-03-11, under 510(k) number K955928.

Who is the listed applicant for BARBITURATE EIA ESSAY (MODIFICATION)?

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 BARBITURATE EIA ESSAY (MODIFICATION)?

The FDA product code for BARBITURATE EIA ESSAY (MODIFICATION) is DIS.

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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: DIS)

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.

K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis CorporationK092268RANDOX BARITURATES ASSAYRandox Laboratories, Ltd.K110515UCP DRUG SCREENING TEST CUPSUcp Biosciences, Inc.K070098QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SCPhamatech, Inc.K070009AT HOME DRUG TEST MODELS, 9308T AND 9308XPhamatech, Inc.K062165VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSOrtho-Clinical Diagnostics

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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