510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850191Substantially Equivalent

Digilab 750 Automated Perimeter W/ibm Person/compu

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

K850191 is the FDA 510(k) clearance record for DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU, 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 K850191.

Clearance record

Decision date
Received
(45 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 180 Cabot St., Beverly MA
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