Home / 510(k) Clearances / K962060

510(k) K962060

STREP A OIA MAX by Biostar, Inc. — Product Code GTZ

K962060 is an FDA 510(k) premarket notification submitted by Biostar, Inc. for the device "STREP A OIA MAX". The FDA issued a decision of Substantially Equivalent on July 23, 1997. The device falls under product code GTZ (Antisera, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Biostar, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1997
Date Received
May 28, 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 Biostar, Inc.

  • K991829 — CDTOX A OIA (November 2, 1999)
  • K991828 — STREP B OIA (August 19, 1999)
  • K981651 — AB FLU OIA (November 25, 1998)
  • K951010 — CHLAMYDIA OIA (October 7, 1995)
  • K936112 — STREP B OIA (July 6, 1994)

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)
  • 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)
  • K960712 — BINAX STREP A TEST (March 22, 1996)

FDA data resources