510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211115Substantially Equivalent

A1AT Genotyping Test

Progenika Biopharma S.A., A Grifols Company, Derio, ES / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211115 is the FDA 510(k) clearance record for A1AT Genotyping Test, a class II device, cleared for Progenika Biopharma S.A., A Grifols Company on under FDA product code PZH (Serpina1 Variant Detection System). FDA's definition for product code PZH reads: "This is a qualitative DNA detection in vitro diagnostic test to be used in conjunction with a visualization instrument and its software. This test is for the simultaneous detection and identification of allelic variants found in the...". FDA records list 4 510(k) clearances for Progenika Biopharma S.A., A Grifols Company, from to . As of , FDA records show no recalls naming K211115.

Clearance record

Decision date
Received
(29 days to decision)
Product code
PZH Serpina1 Variant Detection System
Regulation
21 CFR 866.5130
Device class
Class II
Review panel
Immunology
Applicant
Progenika Biopharma S.A., A Grifols Company Ibaizabal Bidea, Edificio 504, Parque Tecnológico De Bizkaia, Derio, ES
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZH

Trailing 12 months

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

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