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510(k) K780464

LELECTIVE KINETIC SYSTEM-60 by Hycel, Inc. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1978
Date Received
March 22, 1978
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 Hycel, Inc.

  • K802422 — HYCEL TRIGYCERIDE II TEST (October 6, 1980)
  • K790335 — HYCEL M (February 27, 1979)
  • K782116 — KETOSTEROID TEST, HYCEL-17 (January 26, 1979)
  • K782176 — HYCEL LDH-INT TEST (January 26, 1979)
  • K782100 — HYCEL COUNTER 333 (January 3, 1979)
  • K782102 — HYCEL COUNTER 211 (January 3, 1979)
  • K782101 — HYCEL COUNTER 222 (January 3, 1979)
  • K781004 — HMA URIC ACID TEST (July 27, 1978)
  • K780946 — ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER (July 27, 1978)
  • K780262 — DIRECT UREA NITROGEN TEST (April 5, 1978)

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