510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862530Substantially Equivalent

Rapid as Latex

Dilab, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862530 is the FDA 510(k) clearance record for RAPID AS LATEX, a class I device, cleared for Dilab, Inc. on under FDA product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent). FDA records list 11 510(k) clearances for Dilab, Inc., from to . As of , FDA records show no recalls naming K862530.

Clearance record

Decision date
Received
(293 days to decision)
Product code
GTQ Antistreptolysin - Titer/Streptolysin O Reagent
Regulation
21 CFR 866.3720
Device class
Class I
Review panel
Microbiology
Applicant
Dilab, Inc. 7003 NW 50th St., Miami FL
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