510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832197Substantially Equivalent

Prp-1 Reversed Phase Resin

Hamilton Co, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832197 is the FDA 510(k) clearance record for PRP-1 REVERSED PHASE RESIN, a class I device, cleared for Hamilton Co. on under FDA product code DMZ (Liquid Chromatography, Adsorbent). FDA records list 16 510(k) clearances for Hamilton Co., from to . As of , FDA records show no recalls naming K832197.

Clearance record

Decision date
Received
(36 days to decision)
Product code
DMZ Liquid Chromatography, Adsorbent
Regulation
21 CFR 862.2260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Hamilton Co. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DMZ

Trailing 12 months

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

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