510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002272Substantially Equivalent

Branan Medical Corporation Monitect Pcp Drug Screen Test, Model 160C and 160D

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

K002272 is the FDA 510(k) clearance record for BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D, cleared for Branan Medical Corp. on under FDA product code LCM (Enzyme Immunoassay, Phencyclidine). FDA records list 24 510(k) clearances for Branan Medical Corp., from to . As of , FDA records show no recalls naming K002272.

Clearance record

Decision date
Received
(119 days to decision)
Product code
LCM Enzyme Immunoassay, Phencyclidine
Device class
Unclassified
Review panel
Unknown
Applicant
Branan Medical Corp. 10015 Muirlands Rd., Suite E, Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code LCM

Trailing 12 months

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

FDA records show no clearances under product code LCM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCM, 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