510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854735Substantially Equivalent

Mcarthur Microscope Plastic Version with Acc.

Portable Medical Laboratories, Inc., Solana Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854735 is the FDA 510(k) clearance record for MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC., a class I device, cleared for Portable Medical Laboratories, Inc. on under FDA product code IBJ (Light, Microscope). FDA records list 9 510(k) clearances for Portable Medical Laboratories, Inc., from to . As of , FDA records show no recalls naming K854735.

Clearance record

Decision date
Received
(15 days to decision)
Product code
IBJ Light, Microscope
Regulation
21 CFR 864.3600
Device class
Class I
Review panel
Pathology
Applicant
Portable Medical Laboratories, Inc. P.O. Box 667, Solana Beach CA
Third party review
No

Clearances, product code IBJ

Trailing 12 months

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

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