510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K782175Substantially Equivalent

Cartridge Holder, Rcm 100

Waters Assoc., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K782175 is the FDA 510(k) clearance record for CARTRIDGE HOLDER, RCM 100, a class I device, cleared for Waters Assoc., Inc. on under FDA product code KIE (Apparatus, High Pressure Liquid Chromatography). FDA records list 16 510(k) clearances for Waters Assoc., Inc., from to . As of , FDA records show no recalls naming K782175.

Clearance record

Decision date
Received
(49 days to decision)
Product code
KIE Apparatus, High Pressure Liquid Chromatography
Regulation
21 CFR 862.2260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Waters Assoc., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KIE

Trailing 12 months

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

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