510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890768Substantially Equivalent

Pneumocystis Carinii Immunofluorescence Test Kit

Genetic Systems Corp., Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890768 is the FDA 510(k) clearance record for PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT, a class II device, cleared for Genetic Systems Corp. on under FDA product code LYF (Pneumocystis Carinii). FDA records list 12 510(k) clearances for Genetic Systems Corp., from to . As of , FDA records show no recalls naming K890768.

Clearance record

Decision date
Received
(34 days to decision)
Product code
LYF Pneumocystis Carinii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Applicant
Genetic Systems Corp. 3005 First Ave., Seattle WA
Third party review
No

Clearances, product code LYF

Trailing 12 months

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

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