510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192485Substantially Equivalent

BioCode Respiratory Pathogen Panel (RPP)

Applied BioCode, Inc., Santa Fe Springs CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192485 is the FDA 510(k) clearance record for BioCode Respiratory Pathogen Panel (RPP), a class II device, cleared for Applied BioCode, Inc. on under FDA product code OCC (Respiratory Virus Panel Nucleic Acid Assay System). FDA's definition for product code OCC reads: "A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The...". FDA records list 5 510(k) clearances for Applied BioCode, Inc., from to . As of , FDA records show no recalls naming K192485.

Clearance record

Decision date
Received
(104 days to decision)
Product code
OCC Respiratory Virus Panel Nucleic Acid Assay System
Regulation
21 CFR 866.3980
Device class
Class II
Review panel
Microbiology
Applicant
Applied BioCode, Inc. 10020 Pioneer Blvd. Suite 102, Santa Fe Springs CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCC

Trailing 12 months
2 clearances under product code OCC in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OCC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260