510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081719Substantially Equivalent

Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System

Stanbio Laboratory, Boerne TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081719 is the FDA 510(k) clearance record for STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM, a class II device, cleared for Stanbio Laboratory on under FDA product code GKR (System, Hemoglobin, Automated). FDA records list 47 510(k) clearances for Stanbio Laboratory, from to . As of , FDA records show one recall naming K081719.

Clearance record

Decision date
Received
(30 days to decision)
Product code
GKR System, Hemoglobin, Automated
Regulation
21 CFR 864.5620
Device class
Class II
Review panel
Hematology
Applicant
Stanbio Laboratory 1261 N. Main St., Boerne TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GKR

Trailing 12 months

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

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