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
K870486Substantially Equivalent

Earle's Balanced Salts (Ebss) Hybri-Max #E9509

Sigma Chemical Co., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870486 is the FDA 510(k) clearance record for EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509, a class I device, cleared for Sigma Chemical Co. on under FDA product code KIP (Formulations, Balanced Salt Solutions). FDA records list 231 510(k) clearances for Sigma Chemical Co., from to . As of , FDA records show no recalls naming K870486.

Clearance record

Decision date
Received
(55 days to decision)
Product code
KIP Formulations, Balanced Salt Solutions
Regulation
21 CFR 864.2875
Device class
Class I
Review panel
Hematology
Applicant
Sigma Chemical Co. P.O. Box 14508, St. Louis MO
Third party review
No

Clearances, product code KIP

Trailing 12 months

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

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