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FDA 510(k)

USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400

K-Number: K935629 · 1994-04-12

ApplicantU.S. Drug Testing, Inc.
Decision Date1994-04-12
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400 is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Drug Testing, Inc.. It received FDA 510(k) clearance on 1994-04-12 under 510(k) number K935629. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400?

USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400 is a medical device that received FDA 510(k) clearance on 1994-04-12. The listed applicant is U.S. Drug Testing, Inc.. The 510(k) number is K935629.

When did USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400 receive FDA 510(k) clearance?

USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400 received FDA 510(k) clearance on 1994-04-12, under 510(k) number K935629.

Who is the listed applicant for USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400?

The FDA 510(k) record lists U.S. Drug Testing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400?

The FDA product code for USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400 is LCM.

Related Clinical Trials

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Other records listing U.S. Drug Testing, 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.

K940912USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500K934693AMPHETAMINE TEST SYSTEMK932318USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200K931227USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000K930985USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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