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510(k) K770638

DETECTOR, UV, MOLEL GC-55 by Peokin-Elmer Corp. — Product Code KIE

K770638 is an FDA 510(k) premarket notification submitted by Peokin-Elmer Corp. for the device "DETECTOR, UV, MOLEL GC-55". The FDA issued a decision of Substantially Equivalent on June 24, 1977. The device falls under product code KIE (Apparatus, High Pressure Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. Peokin-Elmer Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1977
Date Received
April 4, 1977
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 Peokin-Elmer Corp.

  • K770639 — DETECTOR, IR, MODEL GC-33 (June 24, 1977)

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