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510(k) K791355

VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT by Ventrex Laboratories, Inc. — Product Code DPO

K791355 is an FDA 510(k) premarket notification submitted by Ventrex Laboratories, Inc. for the device "VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on August 10, 1979. The device falls under product code DPO (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.), a Class II device regulated under 21 CFR 862.3320. Ventrex Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1979
Date Received
July 21, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Ventrex Laboratories, Inc.

  • K914554 — SPECIFIC IGE EIA-TURBO ASSAY (March 13, 1992)
  • K913833 — VENTREX ALLERGEN DISC (February 21, 1992)
  • K913434 — VENTREX COATED TUBE INTACT PTH (October 25, 1991)
  • K905612 — VENTREX COATED TUBE IGE RADIOIMMUNOASSAY (February 21, 1991)
  • K905636 — VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY (February 7, 1991)
  • K905247 — SHBG IRMA KIT (January 17, 1991)
  • K904330 — TURBO-RAST SPECIFIC IGE ASSAY (December 7, 1990)
  • K903000 — TURBO-RAST SPECIFIC IGE ASSAY (July 31, 1990)
  • K897083 — VENTRESIGN STREP A TEST (January 22, 1990)
  • K895649 — COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. (January 18, 1990)

Other clearances for product code DPO

  • K914833 — IMMULITE DIGOXIN (November 22, 1991)
  • K905719 — ECLIPSE ICA DIGOXIN (January 17, 1991)
  • K864449 — DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (February 2, 1987)
  • K833842 — RIA COAT DIGOXIN (January 17, 1984)
  • K832163 — SOPHEIA DIGOXIN EIA KIT (August 12, 1983)
  • K830962 — IMMUCHEM COVALENT-COAT RIA KIT (May 4, 1983)
  • K811932 — COAT-A-COUNT DIGOXIN RIA (July 23, 1981)
  • K811776 — KALLESTAD QUANTICOAT 125 DIGOXIN (July 10, 1981)
  • K800205 — RIA PHASE DIGOXIN (March 19, 1980)
  • K791325 — AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM (August 16, 1979)

FDA data resources