Home / 510(k) Clearances / K782116

510(k) K782116

KETOSTEROID TEST, HYCEL-17 by Hycel, Inc. — Product Code CCY

K782116 is an FDA 510(k) premarket notification submitted by Hycel, Inc. for the device "KETOSTEROID TEST, HYCEL-17". The FDA issued a decision of Substantially Equivalent on January 26, 1979. The device falls under product code CCY (Zimmerman (Spectrophotometric), 17-Ketosteroids), a Class I device regulated under 21 CFR 862.1430. Hycel, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1979
Date Received
December 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Zimmerman (Spectrophotometric), 17-Ketosteroids
Device Class
Class I
Regulation Number
862.1430
Review Panel
CH
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)
  • K782101 — HYCEL COUNTER 222 (January 3, 1979)
  • K782102 — HYCEL COUNTER 211 (January 3, 1979)
  • K782100 — HYCEL COUNTER 333 (January 3, 1979)
  • K781004 — HMA URIC ACID TEST (July 27, 1978)
  • K780946 — ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER (July 27, 1978)
  • K780464 — LELECTIVE KINETIC SYSTEM-60 (May 3, 1978)
  • K780262 — DIRECT UREA NITROGEN TEST (April 5, 1978)

FDA data resources