510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864752Substantially Equivalent

Abbott Testpack(tm) Strep a Positive Control

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

K864752 is the FDA 510(k) clearance record for ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL, 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 K864752.

Clearance record

Decision date
Received
(83 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
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