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510(k) K780946

ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER by Hycel, Inc. — Product Code JPJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
June 9, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Red-Cell Indices, Calculated
Device Class
Class II
Regulation Number
864.5300
Review Panel
HE
Submission Type

Other clearances by Hycel, Inc.

  • K802422 — HYCEL TRIGYCERIDE II TEST (October 6, 1980)
  • K790335 — HYCEL M (February 27, 1979)
  • K782176 — HYCEL LDH-INT TEST (January 26, 1979)
  • K782116 — KETOSTEROID TEST, HYCEL-17 (January 26, 1979)
  • K782102 — HYCEL COUNTER 211 (January 3, 1979)
  • K782100 — HYCEL COUNTER 333 (January 3, 1979)
  • K782101 — HYCEL COUNTER 222 (January 3, 1979)
  • K781004 — HMA URIC ACID TEST (July 27, 1978)
  • K780464 — LELECTIVE KINETIC SYSTEM-60 (May 3, 1978)
  • K780262 — DIRECT UREA NITROGEN TEST (April 5, 1978)

Other clearances for product code JPJ

  • K904675 — QBC SYSTEM MCHC (November 2, 1990)
  • K761304 — JTB 700 HEMATOLOGY ANALYZER (February 1, 1977)