510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K772337Substantially Equivalent

Urinary 17-Ketosteriod/17

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

K772337 is the FDA 510(k) clearance record for URINARY 17-KETOSTERIOD/17, a class I device, cleared for Eppendorf-Brinkmann, Inc. on under FDA product code CDG (Chromatography Separation/Zimmerman 17-Ketogenic Steroids). FDA records list 4 510(k) clearances for Eppendorf-Brinkmann, Inc., from to . As of , FDA records show no recalls naming K772337.

Clearance record

Decision date
Received
(21 days to decision)
Product code
CDG Chromatography Separation/Zimmerman 17-Ketogenic Steroids
Regulation
21 CFR 862.1385
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Eppendorf-Brinkmann, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CDG

Trailing 12 months

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

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