510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895816Substantially Equivalent

Bio-Rad Blind Perfor. Specimen Set for Nida Reg.

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

K895816 is the FDA 510(k) clearance record for BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG., a class I device, cleared for Bio-Rad on under FDA product code DIF (Drug Mixture Control Materials). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K895816.

Clearance record

Decision date
Received
(69 days to decision)
Product code
DIF Drug Mixture Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Bio-Rad 3726 E. Miraloma Ave., Anaheim CA
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DIF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260