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FDA 510(k)

RAPID TOX CUP

K-Number: K073078 · 2008-05-30

ApplicantAmerican Bio Medica Corp.
Decision Date2008-05-30
Product CodeLAG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RAPID TOX CUP is the device name listed in this FDA 510(k) record. The listed applicant is American Bio Medica Corp.. It received FDA 510(k) clearance on 2008-05-30 under 510(k) number K073078. The device is classified under product code LAG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID TOX CUP?

RAPID TOX CUP is a medical device that received FDA 510(k) clearance on 2008-05-30. The listed applicant is American Bio Medica Corp.. The 510(k) number is K073078.

When did RAPID TOX CUP receive FDA 510(k) clearance?

RAPID TOX CUP received FDA 510(k) clearance on 2008-05-30, under 510(k) number K073078.

Who is the listed applicant for RAPID TOX CUP?

The FDA 510(k) record lists American Bio Medica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPID TOX CUP?

The FDA product code for RAPID TOX CUP is LAG.

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Other records listing American Bio Medica Corp. 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.

K170222Rapid Tox Cup IIK060760RAPIDONE-BUPRENORPHINE TESTK053422RAPIDONE-COCAINE-150 TESTK053359RAPIDTOXK041696RAPID READERK041712'RAPIDTEC 4' TEST

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Related Devices (Code: LAG)

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.

K062575MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMPPrinceton BioMeditech Corp.K990786ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/Princeton BioMeditech Corp.K983501ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/Princeton BioMeditech Corp.

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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