510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972182Substantially Equivalent

Abbott Strep a Controls

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

K972182 is the FDA 510(k) clearance record for ABBOTT STREP A CONTROLS, a class I device, cleared for Abbott Diagnostics on under FDA product code MJZ (Kit, Direct Antigen, Positive Control). FDA records list 28 510(k) clearances for Abbott Diagnostics, from to . As of , FDA records show no recalls naming K972182.

Clearance record

Decision date
Received
(76 days to decision)
Product code
MJZ Kit, Direct Antigen, Positive Control
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Abbott Diagnostics 200 Abbott Park Rd., Abbott Park IL
510(k) summary
Summary
Third party review
No

Clearances, product code MJZ

Trailing 12 months

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

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