510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K020489Substantially Equivalent

G7 Automated Hplc Analyzer, Beta-Thalassemia Mode

Tosoh Medics, Inc., South San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020489 is the FDA 510(k) clearance record for G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE, a class II device, cleared for Tosoh Medics, Inc. on under FDA product code JPD (Hemoglobin A2 Quantitation). FDA records list 41 510(k) clearances for Tosoh Medics, Inc., from to . As of , FDA records show 2 recalls naming K020489.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JPD Hemoglobin A2 Quantitation
Regulation
21 CFR 864.7400
Device class
Class II
Review panel
Hematology
Applicant
Tosoh Medics, Inc. 347 Oyster Pt. Blvd.,, South San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JPD

Trailing 12 months

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

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