510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063323Substantially Equivalent

Spectrolyse Pai-1, Model 101201

Sekisui Diagnostics, LLC, Stamford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063323 is the FDA 510(k) clearance record for SPECTROLYSE PAI-1, MODEL 101201, a class II device, cleared for American Diagnostica, Inc. on under FDA product code GGP (Test, Qualitative And Quantitative Factor Deficiency). FDA records list 21 510(k) clearances for Sekisui Diagnostics, LLC, from to . As of , FDA records show 2 recalls naming K063323.

Clearance record

Decision date
Received
(285 days to decision)
Product code
GGP Test, Qualitative And Quantitative Factor Deficiency
Regulation
21 CFR 864.7290
Device class
Class II
Review panel
Hematology
Applicant
American Diagnostica, Inc. 500 W. Ave., Stamford CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GGP

Trailing 12 months

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

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