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510(k) K771154

CPK-INT TEST by Hycel, Inc.

K771154 is an FDA 510(k) premarket notification submitted by Hycel, Inc. for the device "CPK-INT TEST". The FDA issued a decision of Substantially Equivalent on July 21, 1977. Hycel, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1977
Date Received
June 28, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K782102 — HYCEL COUNTER 211 (January 3, 1979)
  • K782100 — HYCEL COUNTER 333 (January 3, 1979)
  • K782101 — HYCEL COUNTER 222 (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)

FDA data resources