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
K870580Substantially Equivalent

Mlc Normal Serum

Rjo Biologicals, Inc., Kansas City MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870580 is the FDA 510(k) clearance record for MLC NORMAL SERUM, a class I device, cleared for Rjo Biologicals, Inc. on under FDA product code KIS (Sera, Animal And Human). FDA records list one 510(k) clearance for Rjo Biologicals, Inc. As of , FDA records show no recalls naming K870580.

Clearance record

Decision date
Received
(56 days to decision)
Product code
KIS Sera, Animal And Human
Regulation
21 CFR 864.2800
Device class
Class I
Review panel
Hematology
Applicant
Rjo Biologicals, Inc. 6038 Troost Ave., Kansas City MO
Third party review
No

Clearances, product code KIS

Trailing 12 months

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

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