510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K922490Substantially Equivalent

Abbott Strep a Controls

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922490 is the FDA 510(k) clearance record for ABBOTT STREP A CONTROLS, a class I device, cleared for Abbott Laboratories on under FDA product code GTY (Antigens, All Groups, Streptococcus Spp.). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K922490.

Clearance record

Decision date
Received
(56 days to decision)
Product code
GTY Antigens, All Groups, Streptococcus Spp.
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Applicant
Abbott Laboratories One Abbott Park Rd., Abbott Park IL
510(k) summary
Statement
Third party review
No

Clearances, product code GTY

Trailing 12 months
1 clearance under product code GTY in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GTY, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260