510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852506Substantially Equivalent

Bioglas Microcarrier Bead

Solohill Engineering, Inc., Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852506 is the FDA 510(k) clearance record for BIOGLAS MICROCARRIER BEAD, a class I device, cleared for Solohill Engineering, Inc. on under FDA product code KJB (Apparatus, Roller). FDA records list one 510(k) clearance for Solohill Engineering, Inc. As of , FDA records show no recalls naming K852506.

Clearance record

Decision date
Received
(30 days to decision)
Product code
KJB Apparatus, Roller
Regulation
21 CFR 864.2240
Device class
Class I
Review panel
Hematology
Applicant
Solohill Engineering, Inc. 323 E. William, Suite 44, Ann Arbor MI
Third party review
No

Clearances, product code KJB

Trailing 12 months

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

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