510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882149Substantially Equivalent

Minifuge, Model 70

Utah Bioresearch, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882149 is the FDA 510(k) clearance record for MINIFUGE, MODEL 70, a class I device, cleared for Utah Bioresearch, Inc. on under FDA product code GPG (Antigen, Latex Agglutination, Trichinella Spiralis). FDA records list one 510(k) clearance for Utah Bioresearch, Inc. As of , FDA records show no recalls naming K882149.

Clearance record

Decision date
Received
(39 days to decision)
Product code
GPG Antigen, Latex Agglutination, Trichinella Spiralis
Regulation
21 CFR 866.3850
Device class
Class I
Review panel
Microbiology
Applicant
Utah Bioresearch, Inc. Suite 222, Salt Lake City UT
Third party review
No

Clearances, product code GPG

Trailing 12 months

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

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