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510(k) K780946

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

K780946 is an FDA 510(k) premarket notification submitted by Hycel, Inc. for the device "ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code JPJ (Red-Cell Indices, Calculated), a Class II device regulated under 21 CFR 864.5300. Hycel, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K782101 — HYCEL COUNTER 222 (January 3, 1979)
  • K782100 — HYCEL COUNTER 333 (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)

FDA data resources