510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862630Substantially Equivalent

Mycoplasma Pneumoniae Antibody Latex Test System

Medical Diagnostic Technologies, Inc., Augusta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862630 is the FDA 510(k) clearance record for MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM, a class I device, cleared for Medical Diagnostic Technologies, Inc. on under FDA product code GSA (Antisera, All Mycoplasma Spp.). FDA records list 57 510(k) clearances for Medical Diagnostic Technologies, Inc., from to . As of , FDA records show no recalls naming K862630.

Clearance record

Decision date
Received
(55 days to decision)
Product code
GSA Antisera, All Mycoplasma Spp.
Regulation
21 CFR 866.3375
Device class
Class I
Review panel
Microbiology
Applicant
Medical Diagnostic Technologies, Inc. 3351 Wrightsboro Rd., Augusta GA
Third party review
No

Clearances, product code GSA

Trailing 12 months

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

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