510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831055Substantially Equivalent

Hemoglobin Electrophoresis Meth on the-

Olympus Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831055 is the FDA 510(k) clearance record for HEMOGLOBIN ELECTROPHORESIS METH ON THE-, a class II device, cleared for Olympus Corp. on under FDA product code JBO (Test, Euglobulin Lysis). FDA records list 149 510(k) clearances for Olympus Corp., from to . As of , FDA records show no recalls naming K831055.

Clearance record

Decision date
Received
(68 days to decision)
Product code
JBO Test, Euglobulin Lysis
Regulation
21 CFR 864.7275
Device class
Class II
Review panel
Hematology
Applicant
Olympus Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JBO

Trailing 12 months

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

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