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510(k) K782176

HYCEL LDH-INT TEST by Hycel, Inc. — Product Code CFH

K782176 is an FDA 510(k) premarket notification submitted by Hycel, Inc. for the device "HYCEL LDH-INT TEST". The FDA issued a decision of Substantially Equivalent on January 26, 1979. The device falls under product code CFH (Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase), a Class II device regulated under 21 CFR 862.1440. 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 28, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
Device Class
Class II
Regulation Number
862.1440
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)
  • 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)
  • K780262 — DIRECT UREA NITROGEN TEST (April 5, 1978)

Other clearances for product code CFH

  • K050790 — SPOTCHEM II LDH TEST (June 6, 2005)
  • K020484 — CARESIDE LDH (July 3, 2002)
  • K895138 — CLINISTAT LDH REAGENT TEST (October 19, 1989)
  • K894578 — IQ LDH (October 17, 1989)
  • K880630 — LACTATE DEHYDROGENASE (LDH-L) (March 16, 1988)
  • K860349 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (February 28, 1986)
  • K852391 — EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE (October 1, 1985)
  • K842452 — WAKO LDH CII TEST (August 15, 1984)
  • K820768 — COLORIMETRIC LDH REAGENT SET (April 14, 1982)
  • K812836 — LDH REAGENT SET (October 9, 1981)

FDA data resources