510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K842216Substantially Equivalent

Cultureset Hsv Isolation & Id Sys

Ortho Diagnostic Systems, Inc., Carpinteria CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842216 is the FDA 510(k) clearance record for CULTURESET HSV ISOLATION & ID SYS, a class II device, cleared for Ortho Diagnostic Systems, Inc. on under FDA product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2). FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K842216.

Clearance record

Decision date
Received
(239 days to decision)
Product code
GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Ortho Diagnostic Systems, Inc. 125 Mark Ave., Carpinteria CA
Third party review
No

Clearances, product code GQL

Trailing 12 months

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

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