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FDA 510(k)

SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL

K-Number: K993983 · 2000-01-27

ApplicantSyva Co.
Decision Date2000-01-27
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 2000-01-27 under 510(k) number K993983. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL?

SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL is a medical device that received FDA 510(k) clearance on 2000-01-27. The listed applicant is Syva Co.. The 510(k) number is K993983.

When did SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL receive FDA 510(k) clearance?

SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL received FDA 510(k) clearance on 2000-01-27, under 510(k) number K993983.

Who is the listed applicant for SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL?

The FDA 510(k) record lists Syva Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL?

The FDA product code for SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL is LCM.

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Other records listing Syva Co. 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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULK011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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Related Devices (Code: LCM)

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.

K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics CorporationK203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK163220Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc.K131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEOmega Laboratories, Inc.K122703RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTORBiophor Diagnostics, 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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