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FDA 510(k)

QUICKPAC II ONE STEP BARBITURATE TEST

K-Number: K980349 · 1998-03-03

ApplicantSyntron Bioresearch, Inc.
Decision Date1998-03-03
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUICKPAC II ONE STEP BARBITURATE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Syntron Bioresearch, Inc.. It received FDA 510(k) clearance on 1998-03-03 under 510(k) number K980349. 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 QUICKPAC II ONE STEP BARBITURATE TEST?

QUICKPAC II ONE STEP BARBITURATE TEST is a medical device that received FDA 510(k) clearance on 1998-03-03. The listed applicant is Syntron Bioresearch, Inc.. The 510(k) number is K980349.

When did QUICKPAC II ONE STEP BARBITURATE TEST receive FDA 510(k) clearance?

QUICKPAC II ONE STEP BARBITURATE TEST received FDA 510(k) clearance on 1998-03-03, under 510(k) number K980349.

Who is the listed applicant for QUICKPAC II ONE STEP BARBITURATE TEST?

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

What is the FDA product code for QUICKPAC II ONE STEP BARBITURATE TEST?

The FDA product code for QUICKPAC II ONE STEP BARBITURATE TEST is DIS.

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Other records listing Syntron Bioresearch, 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.

K993490QUICKSTRIP ONE STEP OPIATES TESTK993491QUICKPAC II ONE STEP OPIATES TESTK992990QUICKPAC II ONE STEP COCAINE TESTK992748DRUGCHECK X MULTIDRUG SCREENING DEVICEK992207QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEMK990325QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE

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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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