510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K885091Substantially Equivalent

Hemaview Darkfield Microscope System

Technalysis, Inc., Laguna Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885091 is the FDA 510(k) clearance record for HEMAVIEW DARKFIELD MICROSCOPE SYSTEM, a class I device, cleared for Technalysis, Inc. on under FDA product code IBM (Microscope, Phase Contrast). FDA records list 3 510(k) clearances for Technalysis, Inc., from to . As of , FDA records show no recalls naming K885091.

Clearance record

Decision date
Received
(183 days to decision)
Product code
IBM Microscope, Phase Contrast
Regulation
21 CFR 864.3600
Device class
Class I
Review panel
Pathology
Applicant
Technalysis, Inc. 23180 Del Lago, Laguna Hills CA
Third party review
No

Clearances, product code IBM

Trailing 12 months

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

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