510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921075Substantially Equivalent

Phadebact Monoclonal Gc Test, Modification

Karo Bio Diagnostics AB, S-141 44 Huddinge, Sweden, SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921075 is the FDA 510(k) clearance record for PHADEBACT MONOCLONAL GC TEST, MODIFICATION, a class II device, cleared for Karo Bio Diagnostics AB on under FDA product code LIC (Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae). FDA records list one 510(k) clearance for Karo Bio Diagnostics AB. As of , FDA records show no recalls naming K921075.

Clearance record

Decision date
Received
(84 days to decision)
Product code
LIC Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
Regulation
21 CFR 866.3390
Device class
Class II
Review panel
Microbiology
Applicant
Karo Bio Diagnostics AB Lunastigen 3, S-141 44 Huddinge, Sweden, SC
510(k) summary
Statement
Third party review
No

Clearances, product code LIC

Trailing 12 months

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

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