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510(k) K801391

DISC 120 TRANSPORTER by Travenol Laboratories, S.A. — Product Code JZW

K801391 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "DISC 120 TRANSPORTER". The FDA issued a decision of Substantially Equivalent on July 14, 1980. The device falls under product code JZW (Nephelometer), a Class I device regulated under 21 CFR 866.4540. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1980
Date Received
June 13, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nephelometer
Device Class
Class I
Regulation Number
866.4540
Review Panel
IM
Submission Type

Other clearances by Travenol Laboratories, S.A.

  • K874181 — BAXTER BEDSIDE SYSTEM (February 22, 1988)
  • K873894 — CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE (November 5, 1987)
  • K873873 — RESUBMITTED MICRON TRANSFUSION FILTER (October 22, 1987)
  • K873984 — AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) (October 20, 1987)
  • K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (October 13, 1987)
  • K872652 — UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM (September 30, 1987)
  • K870801 — FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD (September 4, 1987)
  • K871908 — IV ADMINISTRATION SET (July 27, 1987)
  • K871471 — CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 (June 12, 1987)
  • K865029 — CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER (April 17, 1987)

Other clearances for product code JZW

  • K001647 — BN PROSPEC SYSTEM (September 26, 2000)
  • K761234 — BEHRING LASER NEPHELOMETER (June 7, 1990)
  • K892223 — BEHRING NEPHELOMETER 100 (May 4, 1989)
  • K873401 — TURBOX (September 23, 1987)
  • K873407 — RRT SYSTEM LASER REFLECTOMETER ANALYZER (September 23, 1987)
  • K801949 — BCM-302 COLLIMATING CONE & COMPENSATIN (October 3, 1980)
  • K792014 — LANCER L-INA BUFFER, POLYMER, WASH SOLU (November 13, 1979)
  • K781006 — IMMUNOCHEMISTRY SYS. MANUAL MODE (August 31, 1978)
  • K761236 — ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. (December 30, 1976)
  • K761235 — LASER STANDARD SERUM (December 30, 1976)

FDA data resources