Home / 510(k) Clearances / K911299

510(k) K911299

EQUIPMENT/MATERIAL DECONTAMINATING KIT by Rohm and Haas Co. — Product Code KIE

K911299 is an FDA 510(k) premarket notification submitted by Rohm and Haas Co. for the device "EQUIPMENT/MATERIAL DECONTAMINATING KIT". The FDA issued a decision of Substantially Equivalent on April 8, 1991. The device falls under product code KIE (Apparatus, High Pressure Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. Rohm and Haas Co. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1991
Date Received
March 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, High Pressure Liquid Chromatography
Device Class
Class I
Regulation Number
862.2260
Review Panel
TX
Submission Type

Other clearances by Rohm and Haas Co.

  • K834435 — CROWN & BRIDGE RESIN (February 21, 1984)
  • K822722 — CROWN S BRIDGE RESIN (September 30, 1982)
  • K820456 — CROWN & BRIDGE RESIN FOR FABRICAT/DE (March 19, 1982)

Other clearances for product code KIE

  • K964588 — WATERS 515 HPLC PUMP (515) (November 29, 1996)
  • K935666 — PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP (April 26, 1994)
  • K924347 — WATERS(TM) 996 PDA (December 11, 1992)
  • K914841 — CHROMATOGRAPHY CLINICAL USE 75JQR (December 10, 1991)
  • K862506 — THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR (July 29, 1986)
  • K844947 — EMIT ANCILLARY REAGENTS (June 28, 1985)
  • K844949 — SYVA SAMPLE SEAL (February 15, 1985)
  • K800556 — DIFFERENTIAL REFRACTIVE INDEX DETECTOR (March 25, 1980)
  • K800516 — DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM. (March 19, 1980)
  • K800289 — LDC SPECTROMONITOR III (February 26, 1980)

FDA data resources