510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862457Substantially Equivalent

Lynx El Microscopy Tissue Processor

Australian Biomedical Corporation, Ltd., Australia, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862457 is the FDA 510(k) clearance record for LYNX EL MICROSCOPY TISSUE PROCESSOR, a class I device, cleared for Australian Biomedical Corporation , Ltd. on under FDA product code IDZ (Cassettes, Tissue). FDA records list 5 510(k) clearances for Australian Biomedical Corporation , Ltd., from to . As of , FDA records show no recalls naming K862457.

Clearance record

Decision date
Received
(16 days to decision)
Product code
IDZ Cassettes, Tissue
Regulation
21 CFR 864.3010
Device class
Class I
Review panel
Pathology
Applicant
Australian Biomedical Corporation , Ltd. 39 Dehavilland Rd., Australia, AU
Third party review
No

Clearances, product code IDZ

Trailing 12 months

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

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