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510(k) K880678

MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY by Ventrex Laboratories, Inc. — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1988
Date Received
February 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
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)
  • K895648 — COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN. (January 18, 1990)

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