510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895128Substantially Equivalent

Biotrack Alt Test Cartridge

Biotrack, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895128 is the FDA 510(k) clearance record for BIOTRACK ALT TEST CARTRIDGE, a class I device, cleared for Biotrack, Inc. on under FDA product code CJJ (Diazo, Alt/Sgpt). FDA records list 16 510(k) clearances for Biotrack, Inc., from to . As of , FDA records show no recalls naming K895128.

Clearance record

Decision date
Received
(50 days to decision)
Product code
CJJ Diazo, Alt/Sgpt
Regulation
21 CFR 862.1030
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Biotrack, Inc. 1058 Huff Ave., Mountain View CA
Third party review
No

Clearances, product code CJJ

Trailing 12 months

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

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