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510(k) K790073

ANALYZER, IMPACT 100 by Gilford Instrument Laboratories, Inc. — Product Code JJI

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, Enzyme, For Clinical Use
Device Class
Class I
Regulation Number
862.2500
Review Panel
CH
Submission Type

Other clearances by Gilford Instrument Laboratories, Inc.

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  • 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)
  • K790072 — ANALYZER, IMPACT 200 (February 22, 1979)
  • K781269 — ELISA SYSTME (December 4, 1978)

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  • K930898 — RADIAS AUTOMATED IMMUNOASSAY SYSTEM (April 21, 1993)
  • K780972 — QUICKRATE REACTION RATE ANALYZER (August 14, 1978)
  • K771591 — MINISTAT-S CHEMISTRY ANALYZER (September 20, 1977)
  • K770401 — LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE (April 26, 1977)