510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K020710Substantially Equivalent

Biotest Hemoglobin Measuring System

Biotest Medizintechnik GmbH, Richmond VA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K020710 is the FDA 510(k) clearance record for BIOTEST HEMOGLOBIN MEASURING SYSTEM, a class II device, cleared for Biotest Medizintechnik GmbH on under FDA product code GKR (System, Hemoglobin, Automated). FDA records list one 510(k) clearance for Biotest Medizintechnik GmbH. As of , FDA records show no recalls naming K020710.

Clearance record

Decision date
Received
(162 days to decision)
Product code
GKR System, Hemoglobin, Automated
Regulation
21 CFR 864.5620
Device class
Class II
Review panel
Hematology
Applicant
Biotest Medizintechnik GmbH 614 N 4th St., Richmond VA
510(k) summary
Statement
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