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
K893975Substantially Equivalent

Double Antibody Glucagon

Siemens Healthcare Diagnostics Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893975 is the FDA 510(k) clearance record for DOUBLE ANTIBODY GLUCAGON, a class I device, cleared for Diagnostic Products Corp. on under FDA product code JME (Radioimmunoassay, Glucagon). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K893975.

Clearance record

Decision date
Received
(151 days to decision)
Product code
JME Radioimmunoassay, Glucagon
Regulation
21 CFR 862.1335
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Diagnostic Products Corp. 5700 W. 96th St., Los Angeles CA
Third party review
No

Clearances, product code JME

Trailing 12 months

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

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