510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K822449Substantially Equivalent

Tpk 1980/1

Plantex USA, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822449 is the FDA 510(k) clearance record for TPK 1980/1, a class II device, cleared for Plantex USA, Inc. on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list one 510(k) clearance for Plantex USA, Inc. As of , FDA records show no recalls naming K822449.

Clearance record

Decision date
Received
(72 days to decision)
Product code
LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Plantex USA, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LCX

Trailing 12 months

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

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