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510(k) K780962

AUTOMATED ENZYME by Hyland Therapeutic Div., Travenol Laboratories — Product Code KSK

K780962 is an FDA 510(k) premarket notification submitted by Hyland Therapeutic Div., Travenol Laboratories for the device "AUTOMATED ENZYME". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code KSK (Solution, Stabilized Enzyme), a Class II device regulated under 21 CFR 864.9400. Hyland Therapeutic Div., Travenol Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
June 12, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Stabilized Enzyme
Device Class
Class II
Regulation Number
864.9400
Review Panel
HE
Submission Type

Other clearances by Hyland Therapeutic Div., Travenol Laboratories

  • K820835 — ALUMINA SILICA-ACTIVATED PARTIAL THROM (April 26, 1982)
  • K820192 — HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM (March 11, 1982)
  • K812220 — NEPHELOMETRIC SOLID TURBIDITY STANDARD (August 18, 1981)
  • K810078 — Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S (February 2, 1981)
  • K810077 — OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. (January 28, 1981)
  • K802610 — ALERT A,HDL-APOLIPOROTEIN A, TEST KIT (January 5, 1981)
  • K791113 — LOW IONIC STRENGTH SOLUTION (LISS) (June 28, 1979)
  • K790249 — TEST CELLS (May 16, 1979)
  • K781225 — GLOBULIN TEST, HUMAN THYROXINE BINDING (August 31, 1978)
  • K780785 — DILUTOR TRANSPORTER (June 14, 1978)

Other clearances for product code KSK

  • K813342 — GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION (March 4, 1982)
  • K813404 — FREEZE DRIED FICIN (February 10, 1982)
  • K810803 — FREEZE DRIED PAPAIN (July 21, 1981)
  • K760123 — AUTOZYME (July 20, 1976)

FDA data resources