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
K852767Substantially Equivalent

Erythocyte Creatine

Panmed, Inc., Three Oaks MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852767 is the FDA 510(k) clearance record for ERYTHOCYTE CREATINE, a class I device, cleared for Panmed, Inc. on under FDA product code JLA (Conversion To Creatinine, Creatine). FDA records list 16 510(k) clearances for Panmed, Inc., from to . As of , FDA records show no recalls naming K852767.

Clearance record

Decision date
Received
(503 days to decision)
Product code
JLA Conversion To Creatinine, Creatine
Regulation
21 CFR 862.1210
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Panmed, Inc. 505 W. Locust, Three Oaks MI
Third party review
No

Clearances, product code JLA

Trailing 12 months

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

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