Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000

K-Number: K060353 · 2006-05-03

ApplicantAcro Biotech, LLC
Decision Date2006-05-03
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 is the device name listed in this FDA 510(k) record. The listed applicant is Acro Biotech, LLC. It received FDA 510(k) clearance on 2006-05-03 under 510(k) number K060353. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000?

ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 is a medical device that received FDA 510(k) clearance on 2006-05-03. The listed applicant is Acro Biotech, LLC. The 510(k) number is K060353.

When did ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 receive FDA 510(k) clearance?

ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 received FDA 510(k) clearance on 2006-05-03, under 510(k) number K060353.

Who is the listed applicant for ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000?

The FDA 510(k) record lists Acro Biotech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000?

The FDA product code for ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 is LCM.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Acro Biotech, LLC 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.

K060355ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000K060354ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000K053037ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100K053034ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000K053033ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000K053035ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000

View all 8 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.

↑