510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K884178Substantially Equivalent

Drug Control Set

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

K884178 is the FDA 510(k) clearance record for DRUG CONTROL SET, a class I device, cleared for Gelman Sciences, Inc. on under FDA product code DIF (Drug Mixture Control Materials). FDA records list 32 510(k) clearances for Gelman Sciences, Inc., from to . As of , FDA records show no recalls naming K884178.

Clearance record

Decision date
Received
(136 days to decision)
Product code
DIF Drug Mixture Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Gelman Sciences, Inc. 600 S Wagner Rd., Ann Arbor MI
Third party review
No

Clearances, product code DIF

Trailing 12 months

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

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