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510(k) K840830

VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN by Ventrex Laboratories, Inc. — Product Code DER

K840830 is an FDA 510(k) premarket notification submitted by Ventrex Laboratories, Inc. for the device "VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN". The FDA issued a decision of Substantially Equivalent on May 21, 1984. The device falls under product code DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5580. Ventrex Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1984
Date Received
February 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5580
Review Panel
IM
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 DER

  • K013249 — TINA-QUANT APOLIPOPROTEIN VER.2 (November 16, 2001)
  • K000921 — BAYER ADVIA IMS SYSTEM; 200 + 3 (May 18, 2000)
  • K993354 — K-ASSAY APO B (October 28, 1999)
  • K993345 — K-ASSAY APO AI (October 25, 1999)
  • K990594 — INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 (April 14, 1999)
  • K983289 — APOLIPOPROTEIN A1 (January 29, 1999)
  • K964294 — N-ASSAY TIA APO A1/B MULTI CALIBRATOR (August 1, 1997)
  • K964296 — N-ASSAY TIA APO B TEST KIT (August 1, 1997)
  • K964292 — N-ASSAY TIA APO A1 TEST KIT (August 1, 1997)
  • K910553 — ROCHE APOLIPOPROTEIN STANDARD (May 8, 1991)

FDA data resources