510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930796Substantially Equivalent

Ise Calibrators for Corning 600 Series Analyzers

Alko Diagnostic Corp., Holliston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930796 is the FDA 510(k) clearance record for ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS, a class I device, cleared for Alko Diagnostic Corp. on under FDA product code JZX (Equipment, Rocket Immunoelectrophoresis). FDA records list 31 510(k) clearances for Alko Diagnostic Corp., from to . As of , FDA records show no recalls naming K930796.

Clearance record

Decision date
Received
(331 days to decision)
Product code
JZX Equipment, Rocket Immunoelectrophoresis
Regulation
21 CFR 866.4830
Device class
Class I
Review panel
Immunology
Applicant
Alko Diagnostic Corp. Alko Park, Holliston MA
510(k) summary
Summary
Third party review
No

Clearances, product code JZX

Trailing 12 months

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

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