510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802934Substantially Equivalent

Mycoplasma Pneumoniae Antigen & Control

Orion Diagnostica, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802934 is the FDA 510(k) clearance record for MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL, a class I device, cleared for Orion Diagnostica, Inc. on under FDA product code GSB (Antigens, Cf, All, Mycoplasma Spp.). FDA records list 32 510(k) clearances for Orion Diagnostica, Inc., from to . As of , FDA records show no recalls naming K802934.

Clearance record

Decision date
Received
(42 days to decision)
Product code
GSB Antigens, Cf, All, Mycoplasma Spp.
Regulation
21 CFR 866.3375
Device class
Class I
Review panel
Microbiology
Applicant
Orion Diagnostica, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GSB

Trailing 12 months

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

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