510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910833Substantially Equivalent

Color Vue Tm- Mycoplasma Pneumoniae

Seradyn, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910833 is the FDA 510(k) clearance record for COLOR VUE TM- MYCOPLASMA PNEUMONIAE, a class I device, cleared for Seradyn, Inc. on under FDA product code GSA (Antisera, All Mycoplasma Spp.). FDA records list 30 510(k) clearances for Seradyn, Inc., from to . As of , FDA records show no recalls naming K910833.

Clearance record

Decision date
Received
(117 days to decision)
Product code
GSA Antisera, All Mycoplasma Spp.
Regulation
21 CFR 866.3375
Device class
Class I
Review panel
Microbiology
Applicant
Seradyn, Inc. P.O. Box 1210, Indianapolis IN
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