510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100304Substantially Equivalent

St Aia Pack Hba1c

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

K100304 is the FDA 510(k) clearance record for ST AIA PACK HBA1C, a class II device, cleared for Tosoh Bioscience, Inc. on under FDA product code LCP (Assay, Glycosylated Hemoglobin). FDA records list 20 510(k) clearances for Tosoh Bioscience, Inc., from to . As of , FDA records show 4 recalls naming K100304.

Clearance record

Decision date
Received
(205 days to decision)
Product code
LCP Assay, Glycosylated Hemoglobin
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Tosoh Bioscience, Inc. 6000 Shoreline Ct., Suite 101, South San Franciso CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCP

Trailing 12 months

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

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