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510(k) K771446

TRANSPORTEO MODULE by Hyland Therapeutic Div., Travenol Laboratories — Product Code JQX

K771446 is an FDA 510(k) premarket notification submitted by Hyland Therapeutic Div., Travenol Laboratories for the device "TRANSPORTEO MODULE". The FDA issued a decision of Substantially Equivalent on August 10, 1977. The device falls under product code JQX (Nephelometer, For Clinical Use), a Class I device regulated under 21 CFR 862.2700. Hyland Therapeutic Div., Travenol Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1977
Date Received
August 1, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nephelometer, For Clinical Use
Device Class
Class I
Regulation Number
862.2700
Review Panel
CH
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)
  • K780962 — AUTOMATED ENZYME (July 27, 1978)

Other clearances for product code JQX

  • K962294 — IMMAGE IMMUNOCHEMISTRY SYSTEM (August 21, 1996)
  • K922273 — ARRAY(R) 360 (August 19, 1992)
  • K885263 — QMS(TM) - THEOPHYLLINE (March 28, 1989)
  • K851253 — TDX ANALYZER W/NEPHELOMETRY CAROUSEL (April 30, 1985)
  • K851234 — A-JUST TURBIDITY METER (April 29, 1985)
  • K801362 — ALBUMIN NEPHELOMETRIC ASSAY (July 21, 1980)
  • K801089 — J.T. BAKER NEPHELOMETER (May 28, 1980)
  • K792045 — BIOVATION NEPHELOMETER (October 30, 1979)
  • K790103 — NEPHELOMETER, MIC-2000 LASER (March 12, 1979)
  • K781554 — RAD-291 (October 11, 1978)

FDA data resources