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510(k) K912889

OIA STREP A by Biosearch Medical Products, Inc. — Product Code GTZ

K912889 is an FDA 510(k) premarket notification submitted by Biosearch Medical Products, Inc. for the device "OIA STREP A". The FDA issued a decision of Substantially Equivalent on October 31, 1991. The device falls under product code GTZ (Antisera, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Biosearch Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1991
Date Received
July 1, 1991
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 Biosearch Medical Products, Inc.

  • K051480 — ENTERAL FEEDING TUBE (October 12, 2005)
  • K970145 — PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) (August 11, 1997)
  • K964871 — BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS (March 3, 1997)
  • K951260 — URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT (September 27, 1995)
  • K944614 — MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM (April 5, 1995)
  • K932295 — NON-BALLOON REPLACEMENT GASTROSTOMY KIT (September 8, 1994)
  • K935045 — BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER (August 19, 1994)
  • K923002 — ENTEROCLYSIS TUBE (June 28, 1994)
  • K934193 — CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST (November 19, 1993)
  • K922987 — LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC. (April 23, 1993)

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