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510(k) K802422

HYCEL TRIGYCERIDE II TEST by Hycel, Inc.

K802422 is an FDA 510(k) premarket notification submitted by Hycel, Inc. for the device "HYCEL TRIGYCERIDE II TEST". The FDA issued a decision of SESP on October 6, 1980. Hycel, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESP ()
Decision Date
October 6, 1980
Date Received
October 6, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Hycel, Inc.

  • K790335 — HYCEL M (February 27, 1979)
  • K782116 — KETOSTEROID TEST, HYCEL-17 (January 26, 1979)
  • K782176 — HYCEL LDH-INT TEST (January 26, 1979)
  • K782102 — HYCEL COUNTER 211 (January 3, 1979)
  • K782101 — HYCEL COUNTER 222 (January 3, 1979)
  • K782100 — HYCEL COUNTER 333 (January 3, 1979)
  • K780946 — ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER (July 27, 1978)
  • K781004 — HMA URIC ACID TEST (July 27, 1978)
  • K780464 — LELECTIVE KINETIC SYSTEM-60 (May 3, 1978)
  • K780262 — DIRECT UREA NITROGEN TEST (April 5, 1978)

FDA data resources