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510(k) K770639

DETECTOR, IR, MODEL GC-33 by Peokin-Elmer Corp. — Product Code KZQ

K770639 is an FDA 510(k) premarket notification submitted by Peokin-Elmer Corp. for the device "DETECTOR, IR, MODEL GC-33". The FDA issued a decision of Substantially Equivalent on June 24, 1977. The device falls under product code KZQ (Chromatography(Gas), Clinical Use), a Class I device regulated under 21 CFR 862.2250. 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
Chromatography(Gas), Clinical Use
Device Class
Class I
Regulation Number
862.2250
Review Panel
TX
Submission Type

Other clearances by Peokin-Elmer Corp.

  • K770638 — DETECTOR, UV, MOLEL GC-55 (June 24, 1977)

Other clearances for product code KZQ

  • K872122 — 8000 SERIES GAS CHROMATOGRAPHS (June 17, 1987)
  • K841891 — VARIAN 3300 & 3400 GAS CHROMATOGRAPHS (July 9, 1984)
  • K832962 — GAS CHROMATOGRAPH 5890A (October 28, 1983)
  • K831387 — HS-100 HEADSPACE SAMPLING ACCESSORY (August 24, 1983)
  • K830147 — SIGMA 300 GAS CHROMATROGRAPH (February 7, 1983)
  • K820283 — SIGMA 2000 GAS CHROMATOGRAPH (February 23, 1982)
  • K820025 — TRACE ANALYTICAL REDUCTION GAS ANALYZ (February 15, 1982)
  • K820071 — MODEL 5790 GAS CHROMATOGRAPH (January 28, 1982)
  • K801745 — VISTA 44 GAS CHROMATOGRAPHY ANALYSIS (August 20, 1980)
  • K791138 — 5880 SERIES OF GAS CHROMATOGRAPHS (July 24, 1979)

FDA data resources