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
K820518Substantially Equivalent

Gelman Glyco-Phore Buffer

Gelman Sciences, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820518 is the FDA 510(k) clearance record for GELMAN GLYCO-PHORE BUFFER, a class II device, cleared for Gelman Sciences, Inc. on under FDA product code JBD (System, Analysis, Electrophoretic Hemoglobin). FDA records list 32 510(k) clearances for Gelman Sciences, Inc., from to . As of , FDA records show no recalls naming K820518.

Clearance record

Decision date
Received
(43 days to decision)
Product code
JBD System, Analysis, Electrophoretic Hemoglobin
Regulation
21 CFR 864.7440
Device class
Class II
Review panel
Hematology
Applicant
Gelman Sciences, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JBD

Trailing 12 months

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

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