510(k) Report

510(k) · Cleared

Cleared

Branan Medical Corperation Monitect Tca Drug Screen Test, Model MC21 and MD21

K010734510(k) TraditionalCleared Jul 30, 2001140-day reviewClass II21 CFR 862.3910

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Branan Medical Corp. · MLK Thin Layer Chromatography, Tricyclic Antidepressant Drugs

Cleared on Jul 30, 2001 after a 140-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jul 30, 2001
Review
140 days
Class
Class II
Product code
MLK
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K010734Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All MLK devices

MLK Thin Layer Chromatography, Tricyclic Antidepressant Drugs: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MLK

FDA has decided no MLK device since 2007.

Median 510(k) review, days · MLK

Too few MLK 510(k)s in any year since 2007 to give a median.

Recalls per year · MLK

No recall names MLK since 2007.

Adverse event reports per year · MLK

No MAUDE report names MLK since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Branan Medical Corp.

13 FDA decisions under this applicant name. See the company

  • K122633Toxcup Drug Screen CupBranan Medical Corp. · 20138 recalls
  • K122752Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug Screen DipcardBranan Medical Corp. · 2013
  • K040203Monitect Mdma Drug Screen Cassette Test, Model MC22; Fastect II Mdma Drug Screen Dipstick Test, Model MF22Branan Medical Corp. · 2004
  • K032057Toxcup Drug Screen Cup Amp/Coc/Met/Opi/PCP/THCBranan Medical Corp. · 20032 recalls
  • K030113Monitect Oxycodone Drug Screen Cassette Test, Model MC 23, Fastect Oxycodone Drug Screen Dipstick Test…Branan Medical Corp. · 20031 recall

Recent decisions in MLK

The MLK category page

  • K022693Instant-View Tca Urine TestAlfa Scientific Designs, Inc. · 2002

https://510kreport.com/device/K010734 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010734: Branan Medical Corperation Monitect Tca Drug Screen Test, Model MC21 and MD21.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010734

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026