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510(k) K962146

EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT by Excel Scientific, Inc. — Product Code GTZ

K962146 is an FDA 510(k) premarket notification submitted by Excel Scientific, Inc. for the device "EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT". The FDA issued a decision of Substantially Equivalent on October 7, 1996. The device falls under product code GTZ (Antisera, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Excel Scientific, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1996
Date Received
June 3, 1996
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 Excel Scientific, Inc.

  • K971286 — EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST (May 8, 1997)
  • K970467 — EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT (March 18, 1997)
  • K970424 — EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST (March 6, 1997)
  • K970425 — EZ SURE URINE DIPSTICK PREGNANCY HOME TEST (March 6, 1997)
  • K963231 — EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST (December 4, 1996)
  • K962580 — EZ SURE ONESTEP EARLY PREGNANCY TEST (August 29, 1996)
  • K955707 — ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT (May 2, 1996)

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)
  • K955108 — CARDS Q.S. STREP A (April 15, 1996)
  • K960712 — BINAX STREP A TEST (March 22, 1996)

FDA data resources