510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924289Substantially Equivalent

Kallestad Rsv Microplate Eia

Bio-Rad Laboratories Inc., Chaska MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924289 is the FDA 510(k) clearance record for KALLESTAD RSV MICROPLATE EIA, a class I device, cleared for Bio-Rad Laboratories, Inc. on under FDA product code MCE (Respiratory Syncytial Virus - Elisa). FDA records list 128 510(k) clearances for Bio-Rad Laboratories, Inc., from to . As of , FDA records show no recalls naming K924289.

Clearance record

Decision date
Received
(175 days to decision)
Product code
MCE Respiratory Syncytial Virus - Elisa
Regulation
21 CFR 866.3480
Device class
Class I
Review panel
Microbiology
Applicant
Bio-Rad Laboratories, Inc. 1000 Lake Hazeltine Dr., Chaska MN
510(k) summary
Summary
Third party review
No

Clearances, product code MCE

Trailing 12 months

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

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