510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K772188Substantially Equivalent

Fsh Ria Kit (125I)

Siemens Healthcare Diagnostics Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K772188 is the FDA 510(k) clearance record for FSH RIA KIT (125I), a class I device, cleared for Diagnostic Products Corp. on under FDA product code FSH (Tray, Surgical, Needle). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K772188.

Clearance record

Decision date
Received
(27 days to decision)
Product code
FSH Tray, Surgical, Needle
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Diagnostic Products Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FSH

Trailing 12 months

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

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