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
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K260613Substantially Equivalent

AMI™ Plasma Cartridge, AMI™

Sequitur Health Corp., Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(188 days to decision)
Product code
JID Photometric Method, Ammonia
Regulation
21 CFR 862.1065
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Sequitur Health Corp. 6161 E Mayo Blvd., Phoenix AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JID

Trailing 12 months
1 clearance under product code JID in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JID, 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 20261
October 20260