510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010734Substantially Equivalent

Branan Medical Corperation Monitect Tca Drug Screen Test, Model Mc21 and Md21

Branan Medical Corp., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010734 is the FDA 510(k) clearance record for BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21, a class II device, cleared for Branan Medical Corp. on under FDA product code MLK (Thin Layer Chromatography, Tricyclic Antidepressant Drugs). FDA records list 24 510(k) clearances for Branan Medical Corp., from to . As of , FDA records show no recalls naming K010734.

Clearance record

Decision date
Received
(140 days to decision)
Product code
MLK Thin Layer Chromatography, Tricyclic Antidepressant Drugs
Regulation
21 CFR 862.3910
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Branan Medical Corp. 10015 Muirlands Rd., Suite E, Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code MLK

Trailing 12 months

FDA records hold no clearances under product code MLK in the trailing twelve months.

FDA records show no clearances under product code MLK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MLK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260