510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842300Substantially Equivalent

Onpg Disks

Irvine Diagnostic Services, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842300 is the FDA 510(k) clearance record for ONPG DISKS, a class I device, cleared for Irvine Diagnostic Services on under FDA product code JSF (Culture Media, Single Biochemical Test). FDA records list 10 510(k) clearances for Irvine Diagnostic Services, from to . As of , FDA records show no recalls naming K842300.

Clearance record

Decision date
Received
(11 days to decision)
Product code
JSF Culture Media, Single Biochemical Test
Regulation
21 CFR 866.2320
Device class
Class I
Review panel
Microbiology
Applicant
Irvine Diagnostic Services 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JSF

Trailing 12 months

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

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