QUANTI-TEST SYSTEM— 510(k) K982578
Substantially EquivalentPanatrex, Inc.
FDA 510(k) clearance K982578 for QUANTI-TEST SYSTEM, Substantially Equivalent on 1998-09-02. Applicant: Panatrex, Inc.. Device class: 2.
Clearance details
- Applicant
- Panatrex, Inc.
- Product code
- Code SCL
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code SCL
view all- K250983 — Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
- K222385 — Bifurcated Needle
- K182582 — Oryum and Ovem Epidermal Deri Prick Test Applicator
- K172062 — AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray
- K162917 — Allerhope Allergy Skin Tester
More clearances from Panatrex, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.