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510(k) K873130

WASH SOLUTION KIT by A-Kem, Inc. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1987
Date Received
August 10, 1987
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 A-Kem, Inc.

  • K884224 — TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS (December 15, 1988)
  • K884226 — AMYLASE REAGENT KIT FOR ASTRA SYSTEMS (December 9, 1988)
  • K884227 — CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM (December 9, 1988)
  • K884225 — TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS (December 9, 1988)
  • K882586 — A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM (August 8, 1988)
  • K882587 — A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM (August 8, 1988)
  • K873131 — CREATININE REAGENT KIT (October 23, 1987)
  • K873132 — BUN REAGENT KIT (October 23, 1987)
  • K873126 — SODIUM/POTASSIUM REAGENT KIT (October 23, 1987)
  • K873128 — GLUCOSE REAGENT KIT (October 23, 1987)

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