510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860115Substantially Equivalent

Digilab Cambridge Perimeter

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

K860115 is the FDA 510(k) clearance record for DIGILAB CAMBRIDGE PERIMETER, a class I device, cleared for Bio-Rad on under FDA product code HOO (Perimeter, Ac-Powered). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K860115.

Clearance record

Decision date
Received
(45 days to decision)
Product code
HOO Perimeter, 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 HOO

Trailing 12 months

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

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