510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K832175Substantially Equivalent

Digilab 350 the Krakau Perimeter

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

K832175 is the FDA 510(k) clearance record for DIGILAB 350 THE KRAKAU PERIMETER, a class I device, cleared for Bio-Rad on under FDA product code HPT (Perimeter, Automatic, Ac-Powered). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K832175.

Clearance record

Decision date
Received
(41 days to decision)
Product code
HPT Perimeter, Automatic, Ac-Powered
Regulation
21 CFR 886.1605
Device class
Class I
Review panel
Ophthalmic
Applicant
Bio-Rad 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HPT

Trailing 12 months

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

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