510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894780Substantially Equivalent

Immuno/aso

Immunostics, Inc., Ocean NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894780 is the FDA 510(k) clearance record for IMMUNO/ASO, a class I device, cleared for Immunostics Co., Inc. on under FDA product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent). FDA records list 25 510(k) clearances for Immunostics Co., Inc., from to . As of , FDA records show no recalls naming K894780.

Clearance record

Decision date
Received
(81 days to decision)
Product code
GTQ Antistreptolysin - Titer/Streptolysin O Reagent
Regulation
21 CFR 866.3720
Device class
Class I
Review panel
Microbiology
Applicant
Immunostics Co., Inc. 3505 Sunset Ave., Ocean NJ
Third party review
No

Clearances, product code GTQ

Trailing 12 months

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

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