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510(k) K897083

VENTRESIGN STREP A TEST by Ventrex Laboratories, Inc. — Product Code GTZ

K897083 is an FDA 510(k) premarket notification submitted by Ventrex Laboratories, Inc. for the device "VENTRESIGN STREP A TEST". The FDA issued a decision of Substantially Equivalent on January 22, 1990. The device falls under product code GTZ (Antisera, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Ventrex Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1990
Date Received
December 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Groups, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
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)
  • K895649 — COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. (January 18, 1990)
  • K895648 — COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN. (January 18, 1990)

Other clearances for product code GTZ

  • K012521 — BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST (November 30, 2001)
  • K011709 — UNI-GOLD STREP A TEST KIT (November 8, 2001)
  • K010523 — MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (March 15, 2001)
  • K991726 — BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST (August 27, 1999)
  • K971522 — ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II (March 3, 1998)
  • K962060 — STREP A OIA MAX (July 23, 1997)
  • K962296 — STREPTOLEX-STAT (December 16, 1996)
  • K961423 — OSOM STREP A TEST (October 11, 1996)
  • K962146 — EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT (October 7, 1996)
  • K955108 — CARDS Q.S. STREP A (April 15, 1996)

FDA data resources