URINALYSIS REAGENT STRIPS (10 PARAMETERS)— 510(k) K993850
Substantially EquivalentInternational Newtech Development, Inc.
FDA 510(k) clearance K993850 for URINALYSIS REAGENT STRIPS (10 PARAMETERS), Substantially Equivalent on 2000-01-03. Applicant: International Newtech Development, Inc.. Device class: 1.
Clearance details
- Applicant
- International Newtech Development, Inc.
- Product code
- Code JMT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1510
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Delta, B.C., CA
Recent devices under product code JMT
view allMore clearances from International Newtech Development, Inc.
view allRecalls naming K993850
K-number listed on FDA's recall record- Z-0044-2024 — HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10
- Z-0057-2024 — PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993850.
Data sourced from openFDA. This site is unofficial and independent of the FDA.