510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K782116Substantially Equivalent

Ketosteroid Test, Hycel-17

Hycel, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K782116 is the FDA 510(k) clearance record for KETOSTEROID TEST, HYCEL-17, a class I device, cleared for Hycel, Inc. on under FDA product code CCY (Zimmerman (Spectrophotometric), 17-Ketosteroids). FDA records list 19 510(k) clearances for Hycel, Inc., from to . As of , FDA records show no recalls naming K782116.

Clearance record

Decision date
Received
(30 days to decision)
Product code
CCY Zimmerman (Spectrophotometric), 17-Ketosteroids
Regulation
21 CFR 862.1430
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Hycel, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CCY

Trailing 12 months

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

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