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510(k) K791113

LOW IONIC STRENGTH SOLUTION (LISS) by Hyland Therapeutic Div., Travenol Laboratories — Product Code KSG

K791113 is an FDA 510(k) premarket notification submitted by Hyland Therapeutic Div., Travenol Laboratories for the device "LOW IONIC STRENGTH SOLUTION (LISS)". The FDA issued a decision of Substantially Equivalent on June 28, 1979. The device falls under product code KSG (Media, Potentiating For In Vitro Diagnostic Use), a Class II device regulated under 21 CFR 864.9600. Hyland Therapeutic Div., Travenol Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1979
Date Received
June 15, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Potentiating For In Vitro Diagnostic Use
Device Class
Class II
Regulation Number
864.9600
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)
  • K790249 — TEST CELLS (May 16, 1979)
  • K781225 — GLOBULIN TEST, HUMAN THYROXINE BINDING (August 31, 1978)
  • K780962 — AUTOMATED ENZYME (July 27, 1978)
  • K780785 — DILUTOR TRANSPORTER (June 14, 1978)

Other clearances for product code KSG

  • K812565 — ELUTION SOLUTION (October 23, 1981)
  • K812222 — EM-X (September 23, 1981)
  • K800943 — PENTEX BOVINE ALBUMIN 30% SOLUTION (May 8, 1980)
  • K800189 — BOVINE ALBUMIN 22% & 30% SOLUTIONS (February 13, 1980)
  • K791791 — ORTHO ANTIBODY ENHANCEMENT SOLUTION (October 11, 1979)
  • K790973 — LO-ION (June 15, 1979)
  • K790776 — DADE LOW IONIC STRENGTH SOLUITION (LISS) (May 23, 1979)
  • K790498 — LISS REAGENT (April 3, 1979)
  • K781435 — ORTHO LOW IONIC SOLUTION (September 14, 1978)
  • K781397 — EM-V (September 14, 1978)

FDA data resources