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510(k) K791896

CENTRIA PHENYTOIN RIA TEST SET by Ventrex Laboratories, Inc. — Product Code DLP

K791896 is an FDA 510(k) premarket notification submitted by Ventrex Laboratories, Inc. for the device "CENTRIA PHENYTOIN RIA TEST SET". The FDA issued a decision of Substantially Equivalent on October 17, 1979. The device falls under product code DLP (Radioimmunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. Ventrex Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1979
Date Received
September 25, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
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 DLP

  • K894527 — FPR PHENYTOIN KIT (September 25, 1989)
  • K811775 — KALLESTAD ANTISERA TO PHENYTOIN (July 10, 1981)
  • K792640 — FLUOROMATIC PHENYTOIN FIA (January 11, 1980)
  • K770779 — PHENYTOIN RIA KIT (June 17, 1977)

FDA data resources