SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)— 510(k) K983244
Substantially EquivalentTrek Diagnostic Systems, Inc.
FDA 510(k) clearance K983244 for SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM), Substantially Equivalent on 1998-11-30. Applicant: Trek Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Trek Diagnostic Systems, Inc.
- Product code
- Code JTW
- Device class
- Class 1
- Regulation
- 21 CFR 866.2900
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cleveland, OH, US
Recent devices under product code JTW
view all- K121039 — COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
- K061301 — COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM
- K022874 — GEN-PROBE APTIMA COMBO 2 ASSAY
- K013819 — URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
- K993161 — COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
More clearances from Trek Diagnostic Systems, Inc.
view allRecalls naming K983244
K-number listed on FDA's recall record- Z-0327-2023 — Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
- Z-0328-2023 — Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
- Z-0329-2023 — Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
- Z-0330-2023 — Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
- Z-0331-2023 — Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
- Z-0332-2023 — Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
- Z-0333-2023 — Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
- Z-0334-2023 — Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
- Z-0335-2023 — Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983244.
Data sourced from openFDA. This site is unofficial and independent of the FDA.