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FDA 510(k)

QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST

K-Number: K981292 · 1998-05-26

ApplicantSyntron Bioresearch, Inc.
Decision Date1998-05-26
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) 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 1998-05-26 under 510(k) number K981292. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST?

QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST is a medical device that received FDA 510(k) clearance on 1998-05-26. The listed applicant is Syntron Bioresearch, Inc.. The 510(k) number is K981292.

When did QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST receive FDA 510(k) clearance?

QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST received FDA 510(k) clearance on 1998-05-26, under 510(k) number K981292.

Who is the listed applicant for QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) 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 QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST?

The FDA product code for QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST is LCM.

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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

View all 26 devices →

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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