510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171976Substantially Equivalent

Sofia Strep A+ FIA, Sofia 2 Analyzer

Ortho-Clinical Diagnostics, Inc., San Diego, CA / Dual Track, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171976 is the FDA 510(k) clearance record for Sofia Strep A+ FIA, Sofia 2 Analyzer, a class I device, cleared for Quidel Corporation on under FDA product code GTY (Antigens, All Groups, Streptococcus Spp.). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K171976.

Clearance record

Decision date
Received
(174 days to decision)
Product code
GTY Antigens, All Groups, Streptococcus Spp.
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Applicant
Quidel Corporation 12544 High Bluff Dr., Suite 200, San Diego, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GTY

Trailing 12 months
2 clearances under product code GTY in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GTY, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260