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510(k) K823233

SBA 300 CLINICAL CHEMISTRY ANALYZER by Gilford Instrument Laboratories, Inc. — Product Code JJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1982
Date Received
October 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Device Class
Class I
Regulation Number
862.2150
Review Panel
CH
Submission Type

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

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