510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K882998Substantially Equivalent

Acute Phase C-Reactive Protein Latex Agglu. Test

Amtec Diagnostics International, Inc., Conroe TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882998 is the FDA 510(k) clearance record for ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST, a class II device, cleared for Amtec Diagnostics International, Inc. on under FDA product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control). FDA records list 2 510(k) clearances for Amtec Diagnostics International, Inc., from to . As of , FDA records show no recalls naming K882998.

Clearance record

Decision date
Received
(51 days to decision)
Product code
DCK C-Reactive Protein, Antigen, Antiserum, And Control
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
Amtec Diagnostics International, Inc. 1107 Ih-45 S., Conroe TX
Third party review
No

Clearances, product code DCK

Trailing 12 months

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

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