510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890051Substantially Equivalent

Biotrack Aptt Controls

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

K890051 is the FDA 510(k) clearance record for BIOTRACK APTT CONTROLS, a class II device, cleared for Biotrack, Inc. on under FDA product code GIT (Reagent & Control, Partial Thromboplastin Time). FDA records list 16 510(k) clearances for Biotrack, Inc., from to . As of , FDA records show no recalls naming K890051.

Clearance record

Decision date
Received
(48 days to decision)
Product code
GIT Reagent & Control, Partial Thromboplastin Time
Regulation
21 CFR 864.7925
Device class
Class II
Review panel
Hematology
Applicant
Biotrack, Inc. 1058 Huff Ave., Mountain View CA
Third party review
No

Clearances, product code GIT

Trailing 12 months

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

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