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510(k) K772426

17-HYDROXY TEST by Hycel, Inc. — Product Code CDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1978
Date Received
December 27, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Porter Silber Hydrazone, 17-Hydroxycorticosteroids
Device Class
Class I
Regulation Number
862.1385
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)
  • 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)

Other clearances for product code CDB

  • K761271 — URIN. L7-OH CORTICOSTEROID T(NON HYDRO) (February 14, 1977)