510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012943Substantially Equivalent

The Quantech Fastraq Automated Analyzer, and the Quantech Prepaq Total Hcg Test Cartridge

Quantech, Ltd., Northridge CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012943 is the FDA 510(k) clearance record for THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE, a class II device, cleared for Quantech , Ltd. on under FDA product code NAL (Test, Immunoassay, Biosensor, Hcg). FDA records list 3 510(k) clearances for Quantech , Ltd., from to . As of , FDA records show no recalls naming K012943.

Clearance record

Decision date
Received
(140 days to decision)
Product code
NAL Test, Immunoassay, Biosensor, Hcg
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Quantech , Ltd. 9418 Lasaine Ave., Northridge CA
510(k) summary
Summary
Third party review
No

Clearances, product code NAL

Trailing 12 months

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

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