510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973954Substantially Equivalent

Imagen Respiratory Screen

Dako Diagnostics, Ltd., Cambridgeshire, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973954 is the FDA 510(k) clearance record for IMAGEN RESPIRATORY SCREEN, a class I device, cleared for Dako Diagnostics , Ltd. on under FDA product code GNW (Antisera, Cf, Influenza Virus A, B, C). FDA records list 6 510(k) clearances for Dako Diagnostics , Ltd., from to . As of , FDA records show no recalls naming K973954.

Clearance record

Decision date
Received
(74 days to decision)
Product code
GNW Antisera, Cf, Influenza Virus A, B, C
Regulation
21 CFR 866.3330
Device class
Class I
Review panel
Microbiology
Applicant
Dako Diagnostics , Ltd. Denmark House, Angel Drove,, Cambridgeshire, GB
510(k) summary
Summary
Third party review
No

Clearances, product code GNW

Trailing 12 months

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

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