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FDA 510(k)

ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000

K-Number: K053035 · 2006-05-05

ApplicantAcro Biotech, LLC
Decision Date2006-05-05
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 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 2006-05-05 under 510(k) number K053035. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000?

ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 is a medical device that received FDA 510(k) clearance on 2006-05-05. The listed applicant is Acro Biotech, LLC. The 510(k) number is K053035.

When did ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 receive FDA 510(k) clearance?

ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 received FDA 510(k) clearance on 2006-05-05, under 510(k) number K053035.

Who is the listed applicant for ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000?

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 BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000?

The FDA product code for ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 is DIO.

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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# MET001000K060353ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000

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Related Devices (Code: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation

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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