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FDA 510(k)

STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I

K-Number: K001976 · 2000-12-06

ApplicantOraSure Technologies, Inc.
Decision Date2000-12-06
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I is the device name listed in this FDA 510(k) record. The listed applicant is OraSure Technologies, Inc.. It received FDA 510(k) clearance on 2000-12-06 under 510(k) number K001976. 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 STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I?

STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I is a medical device that received FDA 510(k) clearance on 2000-12-06. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K001976.

When did STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I receive FDA 510(k) clearance?

STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I received FDA 510(k) clearance on 2000-12-06, under 510(k) number K001976.

Who is the listed applicant for STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I?

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

What is the FDA product code for STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I?

The FDA product code for STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I is DIS.

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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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