STREPTEX ZL01— 510(k) K842828
Substantially EquivalentWellcome Diagnostics
FDA 510(k) clearance K842828 for STREPTEX ZL01, Substantially Equivalent on 1984-08-15. Applicant: Wellcome Diagnostics. Device class: 1.
Clearance details
- Applicant
- Wellcome Diagnostics
- Product code
- Code JTO
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JTO
view allMore clearances from Wellcome Diagnostics
view allRecalls naming K842828
K-number listed on FDA's recall record- Z-0537-2014 — Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.
- Z-0538-2014 — Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K842828.
Data sourced from openFDA. This site is unofficial and independent of the FDA.