510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891691Substantially Equivalent

Lyphochek Urine Metals Control, Levels I and II

Bio-Rad, Hercules CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891691 is the FDA 510(k) clearance record for LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II, a class I device, cleared for Bio-Rad on under FDA product code DIE (Heavy Metals Control Materials). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K891691.

Clearance record

Decision date
Received
(272 days to decision)
Product code
DIE Heavy Metals Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Bio-Rad 4000 Alfred Nobel Dr., Hercules CA
Third party review
No

Clearances, product code DIE

Trailing 12 months

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

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