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510(k) K790072

ANALYZER, IMPACT 200 by Gilford Instrument Laboratories, Inc. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1979
Date Received
January 11, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

Other clearances by Gilford Instrument Laboratories, Inc.

  • K823233 — SBA 300 CLINICAL CHEMISTRY ANALYZER (November 29, 1982)
  • K821583 — AMES/GILFORD OPTIMATE CLIN. CHEM & THER (June 24, 1982)
  • K802609 — CHEMISTRY ANALYZER IMPACT 400 (November 26, 1980)
  • K801889 — MODEL 203S CLINICAL CHEMISTRY ANALYZER (September 26, 1980)
  • K800085 — SYSTEM 203 CHEMISTRY ANALYZER (February 13, 1980)
  • K792361 — SYSTEM 103 CHEMISTRY ANALYZER (December 27, 1979)
  • K792087 — MICROFLAME PHOTOMETER (November 13, 1979)
  • K791968 — EIA (ELISA) READER (October 17, 1979)
  • K790073 — ANALYZER, IMPACT 100 (February 22, 1979)
  • K781269 — ELISA SYSTME (December 4, 1978)

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