FDA 510(k)

FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD

K-Number: K122752 · 2013-01-30

Decision Date2013-01-30

Product CodeJXN

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD is the device name listed in this FDA 510(k) record. The listed applicant is Branan Medical Corp.. It received FDA 510(k) clearance on 2013-01-30 under 510(k) number K122752. The device is classified under product code JXN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD?

FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD is a medical device that received FDA 510(k) clearance on 2013-01-30. The listed applicant is Branan Medical Corp.. The 510(k) number is K122752.

When did FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD receive FDA 510(k) clearance?

FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD received FDA 510(k) clearance on 2013-01-30, under 510(k) number K122752.

Who is the listed applicant for FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD?

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

What is the FDA product code for FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD?

The FDA product code for FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD is JXN.

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Other records listing Branan Medical Corp. as applicant

K122633TOXCUP DRUG SCREEN CUP K040203MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 K032057TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC K030113MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 K023489QUICKTOX MULTIPLE DRUG DIPCARD K022355QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61

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Related Devices (Code: JXN)

K111363PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIALMedica Corp.K043303ONLINE DAT PROPOXYPHENE PLUSRoche Diagnostics Corp.K040445ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICEACON Laboratories, Inc.K030835'RAPID ONE' - PROPOXYPHENE TESTAmerican Bio Medica Corp.K023795PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)Lin-Zhi International, Inc.K022915INSTANT-VIEW PROPOXYPHENE (PPX) URINE TESTAlfa Scientific Designs, 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.