510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903958Substantially Equivalent

Serofast

Intl. Mycoplasma/Mdc Assoc., Manchester MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903958 is the FDA 510(k) clearance record for SEROFAST, a class I device, cleared for Intl. Mycoplasma/Mdc Assoc. on under FDA product code GSA (Antisera, All Mycoplasma Spp.). FDA records list one 510(k) clearance for Intl. Mycoplasma/Mdc Assoc. As of , FDA records show no recalls naming K903958.

Clearance record

Decision date
Received
(115 days to decision)
Product code
GSA Antisera, All Mycoplasma Spp.
Regulation
21 CFR 866.3375
Device class
Class I
Review panel
Microbiology
Applicant
Intl. Mycoplasma/Mdc Assoc. P.O. Box 641, Manchester MA
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