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510(k) K896109

IMMUNOCARD STREP A TEST by Disease Detection International, Inc. — Product Code GTZ

K896109 is an FDA 510(k) premarket notification submitted by Disease Detection International, Inc. for the device "IMMUNOCARD STREP A TEST". The FDA issued a decision of Substantially Equivalent on November 29, 1989. The device falls under product code GTZ (Antisera, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Disease Detection International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1989
Date Received
October 23, 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 Disease Detection International, Inc.

  • K943252 — PRO-STEP LH OVULATION PREDICTION TEST (October 25, 1994)
  • K925303 — PRO-STEP PT HCG (June 15, 1993)
  • K925125 — PRO-STEP HCG (January 13, 1993)
  • K911826 — IMMUNOCARD HCG ONE STEP (I-S) TEST KIT (July 19, 1991)
  • K902571 — MODIFICATION OF SEROCARD RUBELLA IGG TEST (September 5, 1990)
  • K903070 — SEROCARD HSV IGG ANTIBODY TEST KIT (August 9, 1990)
  • K895912 — IMMUNOCARD HCG II-S TEST KIT (December 1, 1989)
  • K884246 — MODIFIED DDI SEROCARD HERPES IGG TEST KIT (April 10, 1989)
  • K884247 — MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT (April 10, 1989)
  • K884248 — MODIFIED DDI SEROCARD CMV IGG TEST KIT (April 10, 1989)

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