510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K103542Substantially Equivalent

Genstrip Test Strip Model 100-201

Shasta Technologies, LLC, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103542 is the FDA 510(k) clearance record for GENSTRIP TEST STRIP MODEL 100-201, a class II device, cleared for Shasta Technologies, LLC on under FDA product code NBW (System, Test, Blood Glucose, Over The Counter). FDA records list one 510(k) clearance for Shasta Technologies, LLC. As of , FDA records show no recalls naming K103542.

Clearance record

Decision date
Received
(729 days to decision)
Product code
NBW System, Test, Blood Glucose, Over The Counter
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Shasta Technologies, LLC 611 W 5th St., Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBW

Trailing 12 months
4 clearances under product code NBW in the twelve months to October 2026, October 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NBW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20262