510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K852201Substantially Equivalent

Echoclonal Hcg Irma

Bio-Rad, Richmond CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852201 is the FDA 510(k) clearance record for ECHOCLONAL HCG IRMA, a class II device, cleared for Bio-Rad on under FDA product code JHI (Visual, Pregnancy Hcg, Prescription Use). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K852201.

Clearance record

Decision date
Received
(38 days to decision)
Product code
JHI Visual, Pregnancy Hcg, Prescription Use
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bio-Rad 2400 Wright Ave., Richmond CA
Third party review
No

Clearances, product code JHI

Trailing 12 months
1 clearance under product code JHI in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JHI, 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 20261
October 20260