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510(k) K770803

HEMOTOLOGY PRODU&TS (5 IN ALL) by Hycel, Inc. — Product Code GKK

K770803 is an FDA 510(k) premarket notification submitted by Hycel, Inc. for the device "HEMOTOLOGY PRODU&TS (5 IN ALL)". The FDA issued a decision of Substantially Equivalent on July 5, 1977. The device falls under product code GKK (Cyanomethemoglobin), a Class II device regulated under 21 CFR 864.7500. Hycel, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1977
Date Received
May 2, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cyanomethemoglobin
Device Class
Class II
Regulation Number
864.7500
Review Panel
HE
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)
  • 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)

Other clearances for product code GKK

  • K896922 — RAICHEM TM HEMOGLOBIN REAGENT (January 25, 1990)
  • K894951 — MODIFIED HEMOGLOBIN REAGENT SET (October 24, 1989)
  • K883992 — KVM PREPACK HEMATOLOGY REAGENT SET (October 12, 1988)
  • K821202 — HEMOGLOBIN REAGENT SET (May 24, 1982)
  • K771716 — CYMET-PLUS (September 20, 1977)
  • K771090 — UNIPAK HEMOGLOBIN (July 11, 1977)

FDA data resources