SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
FDA 510(k) clearance K233611 · decided 2024-03-26
Clearance details
- K-number
- K233611
- Device name
- SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
- Applicant
- Maine Molecular Quality Controls, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-13
- Decision date
- 2024-03-26
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- PMN
- Device class
- 2
- Regulation number
- 866.3920
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Saco, ME, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit (K261475) | Biofire Defense, LLC | 2026-07-17 |
| FilmArray TF Control Panel M527 (K260577) | Maine Molecular Quality Controls, Inc. | 2026-05-19 |
| MDx-Chex for BCP (K260041) | Streck, LLC | 2026-03-27 |
| MDx-Chex for BCN (K254166) | Streck | 2026-03-23 |
| MDx-Chex for BCY (K254167) | Streck, LLC | 2026-03-17 |
| FilmArray GI Control Panel M238 (K251526) | Maine Molecular Quality Controls, Inc. | 2025-08-14 |
| SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control (K241289) | Maine Molecular Quality Controls, Inc. | 2024-05-30 |
| MDx-Chex for BC-GP (K231221) | Streck | 2023-07-27 |
| MDx-Chex for BC-GN (K231223) | Streck | 2023-07-27 |
| SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control (K230868) | Maine Molecular Quality Controls, Inc. | 2023-04-13 |
| SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (K221253) | Maine Molecular Quality Controls, Inc. | 2023-02-03 |
| BioFire JI Control Panel M420 (K203680) | Maine Molecular Quality Controls, Inc. | 2022-07-22 |
Recalls involving this device
No recalls on record reference this clearance.