510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923195Substantially Equivalent

Myoglobin Elisa Test Kit

Immuno Diagnostic Center, Inc., Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923195 is the FDA 510(k) clearance record for MYOGLOBIN ELISA TEST KIT, a class II device, cleared for Immuno Diagnostic Center, Inc. on under FDA product code DDR (Myoglobin, Antigen, Antiserum, Control). FDA records list 3 510(k) clearances for Immuno Diagnostic Center, Inc., from to . As of , FDA records show no recalls naming K923195.

Clearance record

Decision date
Received
(129 days to decision)
Product code
DDR Myoglobin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5680
Device class
Class II
Review panel
Immunology
Applicant
Immuno Diagnostic Center, Inc. 9978 Monroe Dr., Suite 303, Dallas TX
510(k) summary
Statement
Third party review
No

Clearances, product code DDR

Trailing 12 months

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

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