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510(k) K800916

P1 BLOOD GROUP SUBSTANCE by Travenol Laboratories, S.A. — Product Code KSX

K800916 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "P1 BLOOD GROUP SUBSTANCE". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code KSX (Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use), a Class II device regulated under 21 CFR 864.9160. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1980
Date Received
April 22, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
Device Class
Class II
Regulation Number
864.9160
Review Panel
HE
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 KSX

  • K802534 — GAMMA PI BLOOD GROUP SUBSTANCE (November 12, 1980)
  • K802533 — GAMMA LEWIS BLOOD GROUP SUBSTANCE (November 12, 1980)
  • K781862 — BLOOD GROUP SUBSTANCE A (December 20, 1978)
  • K781896 — BLOOD GROUP SUBSTANCE A,B (December 20, 1978)
  • K781895 — BLOOD GROUP SUBSTANCE B (December 20, 1978)
  • K771488 — P1 BLOOD GROUP SUBSTANCE (November 8, 1977)
  • K771487 — LEWIS BLOOD GROUP SUBSTANCE (November 8, 1977)

FDA data resources