510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971662Substantially Equivalent

Elvis Hsv Id/typing Test System

Ortho-Clinical Diagnostics, Inc., Athens OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971662 is the FDA 510(k) clearance record for ELVIS HSV ID/TYPING TEST SYSTEM, a class II device, cleared for Diagnostic Hybrids, Inc. on under FDA product code GQN (Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K971662.

Clearance record

Decision date
Received
(203 days to decision)
Product code
GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Diagnostic Hybrids, Inc. One President St., Athens OH
510(k) summary
Summary
Third party review
No

Clearances, product code GQN

Trailing 12 months

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

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