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510(k) K800048

LDC CONSTAMETRIC III HIGHT PRESS. SOL. by Laboratory Data Control — Product Code KIE

K800048 is an FDA 510(k) premarket notification submitted by Laboratory Data Control for the device "LDC CONSTAMETRIC III HIGHT PRESS. SOL.". The FDA issued a decision of Substantially Equivalent on January 29, 1980. The device falls under product code KIE (Apparatus, High Pressure Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. Laboratory Data Control has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1980
Date Received
January 9, 1980
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 Laboratory Data Control

  • K800289 — LDC SPECTROMONITOR III (February 26, 1980)
  • K800046 — LDC CHROMATOGRAPHY ACCESSORY MODULE B (February 25, 1980)
  • K800047 — LDC UVIII FIXED WAVELENGTH ULTRAVIOLET (January 21, 1980)

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)
  • K911299 — EQUIPMENT/MATERIAL DECONTAMINATING KIT (April 8, 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)

FDA data resources