ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)— 510(k) K952819
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K952819 for ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC), Substantially Equivalent on 1996-01-26. Applicant: Abbott Laboratories. Device class: 1.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code GTZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Abbott Park, IL, US
Recent devices under product code GTZ
view all- K012521 — BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
- K011709 — UNI-GOLD STREP A TEST KIT
- K010523 — MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
- K991726 — BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI
- K971522 — ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
More clearances from Abbott Laboratories
view allData sourced from openFDA. This site is unofficial and independent of the FDA.