PROLEX (STREPTOCCAL GROUPING LATEX KIT)— 510(k) K934383
Substantially EquivalentPro-Lab, Inc.
FDA 510(k) clearance K934383 for PROLEX (STREPTOCCAL GROUPING LATEX KIT), Substantially Equivalent on 1995-01-27. Applicant: Pro-Lab, Inc.. Device class: 1.
Clearance details
- Applicant
- Pro-Lab, Inc.
- 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
- Richmond Hill, Ontario, CA
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 Pro-Lab, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.