510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K974582Substantially Equivalent

Quickscreen One Step Pcp Screening Test

Phamatech Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974582 is the FDA 510(k) clearance record for QUICKSCREEN ONE STEP PCP SCREENING TEST, cleared for Phamatech on under FDA product code LCM (Enzyme Immunoassay, Phencyclidine). FDA records list 62 510(k) clearances for Phamatech, from to . As of , FDA records show no recalls naming K974582.

Clearance record

Decision date
Received
(58 days to decision)
Product code
LCM Enzyme Immunoassay, Phencyclidine
Device class
Unclassified
Review panel
Unknown
Applicant
Phamatech 9265 Activity Rd., #112-113, San Diego CA
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260