510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K910417Substantially Equivalent

Evidence Biological Indicator

Skyland Scientific Services, Inc., Bozeman MT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910417 is the FDA 510(k) clearance record for EVIDENCE BIOLOGICAL INDICATOR, a class II device, cleared for Skyland Scientific Services, Inc. on under FDA product code FRC (Indicator, Biological Sterilization Process). FDA records list 3 510(k) clearances for Skyland Scientific Services, Inc., from to . As of , FDA records show no recalls naming K910417.

Clearance record

Decision date
Received
(37 days to decision)
Product code
FRC Indicator, Biological Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Skyland Scientific Services, Inc. 2311 S. 7th.Ave., Bozeman MT
Third party review
No

Clearances, product code FRC

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